BIBA Publishing
Reclassification with FFR of ambiguous lesions is safe
Results from a registry suggest that FFR-guided reclassification of the management strategy in patients with ambiguous coronary lesions is safe as it does not adversely affect clinical outcomes.
The transformation of the coronary stent
Adrian Banning charts the evolution of the stent from the original bare metal design to bioabsorbable scaffold and biodegradable polymers. He also looks at the challenges of further improving stent design
Medtronic to resume sales of CoreValve in Germany
A German court ordered the discontinuation, in its entirety, of a prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve system in Germany since 26 August 2013.
First European implant of Mitroflow Valsalva conduit performed
Sorin has announced that the first European implant of its Mitroflow Valsalva conduit device was performed by Roberto di Bartolomeo, chief of the Cardiac Surgery Department at Sant'Orsola-Malpighi Hospital, Bologna, Italy.
Reducer significantly improves functional capabilities in angina patients
Topline results from a multicentre, prospective, randomised, sham-controlled study indicate that a percutaneous device (Neovasc Reducer) significantly improves functional capabilities in patients with refractory angina.
Conservative revascularisation is non-inferior to aggressive revascularisation
The one-year results from the SMART-CASE study indicate that a conservative strategy of only performing percutaneous coronary intervention if the diameter stenosis of the target lesion is >70% is non-inferior to an aggressive strategy of performing PCI if the diameter stenosis is >50%.
Transradial approach is reasonable in women
The SAFE-PCI for Women trial suggests that the transradial approach in women undergoing cardiac catheterisation is associated with significantly less bleeding or vascular complications compared with the transfemoral approach.
PCI and bypass graft surgery: Which intervention and in whom?
Marie-Claude Morice discusses data for CABG vs. data for PCI and how newer generation drug-eluting stents may affect the future treatment of patients with coronary artery disease.
Larger version of Axxess stent now available
Biosensors has a launched a new size of its Axxess bifurcation drug-eluting stent. The new 4.0x9mm size received the CE mark in September and has been specifically designed for the safe and effective treatment of bifurcation lesions involving large main branch vessels and wide bifurcation angulation.
Cardiovascular Research Foundation and Uppsala Clinical Research Center launch joint study to assess intracoronary near infrared spectroscopy
The Cardiovascular Research Foundation (CRF), New York, USA, and the Uppsala Clinical Research Center (UCR), Uppsala, Sweden, have launched a study (PROSPECT II) and a substudy (PROSPECT ABSORB) to assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques.
New device for acute coronary artery perforation
Biotronik's PK Papyrus covered coronary stent has received the CE mark and can now be used for the management of acute coronary artery perforation.
Self-Apposing stent effective for other indications than acute myocardial infarction
Data presented at TCT suggest that the Self-Apposing stent (Stentys) can be used for indications other than acute myocardial infarction (its current indication).
Oxygen therapy reduces infarct size
An Investigational Device Exemption pilot study of Therox's next-generation system for supersaturated oxygen therapy indicated that patients who received the therapy had a 9.6% median infarct size at 30 days.
Medtronic to study renal denervation in patients with moderate hypertension
The FDA has given Medtronic investigational device exemption (IDE) approval to assess the use of renal denervation in patients with moderate uncontrolled hypertension.
Thomas F Lüscher
Thomas F Lüscher is professor and chairman of Cardiology at the University Heart Center, University Hospital Zurich (Switzerland) and the director of Cardiovascular Research, Institute of Physiology, University of Zurich, Switzerland. He has been involved in many pivotal studies. He spoke to Cardiovascular News about this research and other highlights of his career.
Resolute Integrity stent outperforms Promus Element stent for longitudinal strength
Presented at TCT and published in the Lancet, results of DUTCH PEERS negate the notion of class effect with structural stability of "more flexible and highly deliverable devices".
Lotus Valve System meets primary performance endpoint in REPRISE II trial
New data announced at Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrate successful deployment in 120 patients with no severe paravalvular regurgitation at 30 days.
Positive results for degenerative mitral regurgitation patients with MitraClip
The results shows treatment with MitraClip provides clinical benefits and improves quality of life for patients with debilitating mitral valve disease who are at prohibitive surgical risk, it states in a press release.
Drug-eluting balloon revenue to more than double by 2019
The global sales of drug-eluting balloons across the 10 major markets are expected to witness a significant increase over the coming years, from US$164m in 2012 to US$477m in 2019, at a Compound Annual Growth Rate of 16%.
Three-year results from SYMPLICITY HTN-2 shows significant and sustained drops in blood pressure
Three-year data from SYMPLICITY HTN-2, the first and longest-running randomised, controlled clinical trial of renal denervation, continues to demonstrate results consistent with data reported previously at six, 12 and 24-months of follow-up, according to a Medtronic release.
Final results of ADVISE II registry demonstrates performance and utility of iFR Modality
Volcano Corporation announced final results of ADVISE (Adenosine vasodilator independent stenosis evaluation) II, a prospective, double-blind, global, multicentre registry designed to investigate the diagnostic utility of the instant wave-Free Ratio (iFR) Modality in assessing the severity of coronary stenosis.
Lower mortality in STEMI patients with MGuard stent
Data presented at TCT indicate that compared with a control group, InspireMD's MGuard stent is associated with lower mortality in STEMI patients.
1000th patient implanted with ACURATE TA
Symetis has announced that the 1000th implantation of its ACCURATE TA transcatheter aortic valve implantation device has taken place.
World’s first study to evaluate live 3D holographic imaging in interventional cardiology completed
Royal Philips and RealView Imaging have announced that they have completed a clinical study that has demonstrated the feasibility of using an innovative live 3D holographic visualisation and interaction technology to guide minimally-invasive structural heart disease procedures.
Phase II STOP-HF study of JVS-100 in patients with symptomatic heart failure completes enrolment
Juventas Therapeutics announced today that the company has completed enrolment of the STOP-HF trial. STOP-HF is a double-blinded, placebo-controlled, multi-centre trial of its non-viral DNA plasmid therapy JVS-100 for patients with symptomatic heart failure.
Biotronink Japan announces first patients enrolled in BIOFLOW-IV clinical study
Biotronik Japan has announced enrolment of the first patient in the BIOFLOW-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid drug-eluting stent. The high quality and efficacy of Orsiro has already been confirmed by three important trials, BIOFLOW-I, -II, and –III, which demonstrated the safety and efficacy of Orsiro.
Combo dual therapy stent demonstrates excellent early-healing and durable outcomes at 24 months
New clinical data presented at 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium show durable outcomes as well as excellent early healing and optimal neointimal suppression out to 24 months following placement of the Combo dual therapy stent (OrbusNeich).
Six-month results confirm no aortic regurgitation with Direct Flow Medical’s TAVI device
Results from the DISCOVER trial, which were presented at the TCT conference, show that no patients who received the Direct Flow Medical's transcatheter aortic valve implantation (TAVI) system had moderate or severe post-procedural aortic regurgitation at the six-month point.
Positive results in Portico Transfemoral CE Trial reported
St Jude Medical announced positive results for the 23–25mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE mark trial (Portico TF CE Trial). The data was presented at TCT in San Francisco.
EnligHTN I results presented at TCT
St Jude Medical has announced new results from the EnligHTN I study, confirming safe, rapid and sustained reduction in blood pressure measurements a year and a half post-procedure.
CE mark for Lotus Valve System
Boston Scientific has received CE mark for the Lotus Valve System, the company's advanced transcatheter aortic valve implantation (TAVI) technology. This key approval offers a treatment alternative for patients with severe aortic stenosis who are high risk for surgical valve replacement.
MitraClip approved for use in the USA
The FDA has approved Abbott Vascular's MitraClip device as a treatment option for patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery.
Cardiovascular Systems receives coronary FDA approval
Cardiovascular Systems announced that it has received approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.
CoreValve US Pivotal Trial Extreme Risk study to be presented at TCT
Results from the Extreme Risk study of the CoreValve US Pivotal Trial will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference (28 October–1 November, San Francisco, USA), Medtronic has announced.
Scoreflex coronary dilatation catheter associated with less in-stent late loss
A study published in the World Journal of Cardiovascular Diseases indicates that the Scoreflex coronary dilatation catheter (OrbusNeich) is associated with less in-stent late loss compared with a non-compliant balloon.
Medtronic launches new aspiration catheter for coronary thrombus removal in USA
Medtronic's new aspiration catheter, the Export Advance, has a pre-loaded stylet that has been designed to increase the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.
Four-month results for self-apposing stent released at TCT
Data for the self-apposing stent (Stentys) from the APPOSITION IV trial will be disclosed during the upcoming Transcatheter Cardiovascular Therapeutics conference (27 October–1 November, San Francisco, USA).
Jack Lewin is the new president of the Cardiovascular Research Foundation
The Cardiovascular Research Foundation has announced that John (Jack) Lewin has been appointed as its new president and chief executive officer.
First patient treated with Dreams bioresorbable magnesium scaffold
Biotronik has announced that the first patient, as part of a clinical study, has been treated with its bioresorbable magnesium Dreams scaffold.
Therox to present new results for its supersaturated oxygen therapy at TCT
The presentation will include results from the company's multicentre Investigational Device Exemption (IDE) pilot study of a second-generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction.
Access to automatic external defibrillators limited at night time
A Danish study suggests that although the majority of out-of-hospital cardiac arrests occur at night time, at weekends, or in the evening, accessibility to automatic external defibrillators (AEDs) during these times is limited.
Significant mitral regurgitation is not an absolute contraindication for TAVI
M Zeeshan Khawaja (The Rayne Institute, King's College London & St Thomas' Hospital, London, UK) reported at PCR London Valves that more than half of patients with significant mitral regurgitation saw an improvement in mitral regurgitation grade after transcatheter aortic valve implantation (TAVI).
Final patient phase II proof-of-concept study of TRO40303 for acute myocardial infarction completed
The study, a part of the EU-funded MitoCare Project, will evaluate the reduction of reperfusion injury by TRO40303 in acute ST-elevation myocardial infarction (STEMI) patients.
Philips collaborates with Accenture to create first proof-of-concept for delivering vital patient data via Google Glass
Royal Philips and Accenture has announced the creation of a proof-of-concept demonstration that uses a Google Glass head-mounted display for researching ways to improve the effectiveness and efficiency of performing surgical procedures.
New heart valve that does not require open-heart surgery investigated
Bluhm Cardiovascular Institute has announced it has enrolled its first patient in the SALUS trial at Northwestern Memorial Hospital, Chicago, USA, for a movable, non-metallic heart valve.
DESSOLVE I manuscript accepted for publication in JACC: Cardiovascular Interventions
Micell Technologies announced on 8 October that a peer-reviewed article discussing imaging and clinical results of the DESSOLVE I trial of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) was accepted for publication on the JACC: Cardiovascular Interventions website.
Cardionovum initiates launch of Xlimus drug-eluting stent
After receiving the CE mark for its Xlimus sirolimus-eluting stent, Cardionovum has initiated the international market launch of the coronary stent.
Successful first-in-man transcatheter clinical procedure with Revivent-TC System for heart failure completed
BioVentrix has announced the first-in-man use of its Revivent-TC Myocardial Anchoring System, via Less Invasive Ventricular Enhancement (the LIVE procedure). The procedure was performed by Gintaras Kalinauskas and Gierdrius Davidavicius (both of Vilnius University Hospital in Vilnius, Lithuania).
“Significant capability” reported for Enabler-C Catheter System for crossing coronary chronic total occlusions
Thirty per cent of percutaneous coronary intervention (PCI) procedures aimed at the recanalisation of chronic total occlusion fail, with the major cause being the inability of the guidewire to cross the target lesion. The Enabler-C Catheter system is designed to offer a new solution for the treatment of these challenging lesions, according to Endocross.
MitraClip is safe and effective for non-central degenerative mitral regurgitation
A study has indicated that percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbott Vascular) can be performed safely and effectively in both patients with central degenerative mitral regurgitation and those with non-central degenerative mitral regurgitation
Hypertension may protect against cerebrovascular events after TAVI
Data from a registry study suggest that hypertension provides a protective effect against cerebrovascular events after transcatheter aortic valve implantation.
Chaim Lotan
Chaim Lotan is the director of the Heart Institute of The Hadassah-Hebrew University Medical Center (Jerusalem, Israel) and is also course co-director for the Innovations in Cardiovascular Intervention (ICI) meeting (1–3 December, Tel Aviv, Israel). He spoke to Cardiovascular News about his career highlights and the goals of this year's ICI meeting
Serjan D Nikolic is new vice president of therapy development at BioVentrix
BioVentrix has appointed Serjan D Nikolic as its new vice president of therapy development. Nikolic will focus on the clinical implementation of the company's existing surgical and future transcatheter product lines for less-invasive ventricular enhancement known as the "LIVE" procedure.
Two new patents for Cardiological Solutions
Cardiological Solutions has received two new patents for its range of aortic embolic protection devices, which are designed to prevent stroke and other ischaemic complications.
Study to investigate effectiveness of RenalGuard therapy during TAVI
The first patient has been treated in a new study that evaluating the effectiveness of RenalGuard therapy at preventing acute kidney injury in patients undergoing transcatheter aortic valve implantation (TAVI).
Six-month data for Lotus TAVI device show favourable results
Data presented at PCR London Valves indicate that the Lotus transcatheter aortic valve implantation (TAVI) device is not associated with any cases of moderate or severe paravalvular regurgitation in any patient at six months
Successful in vivo validation of its VasoStitch access-and-closure device for TAVI
CardioLogical Solutions reports successful completed in vivo validation of its transcatheter aortic valve implantation (TAVI) access-and-closure device (VasoStitch) and reports its aims to produce a first-in-man clinical study.
Hospital enrols second patient in the SURTAVI trial
El Camino Hospital (Mountain View, USA) announces that it has enrolled its second patient in a global clinical trial comparing the CoreValve System (Medtronic) with surgical aortic valve implantation in patients with severe aortic stenosis who are at intermediate risk for open-heart surgery.
Enrolment concludes in randomised multicentre Synergy coronary stent trial
Boston Scientific has completed enrolment in the EVOLVE II randomised, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy coronary stent system.
JenaValve receives extended CE mark approval for aortic insufficiency
JenaValve Technology has announced it has received CE mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency.
New study will investigate role of robotic angioplasty
Corindus Vascular Robotics has announced that it has launched an extensive study of robotic angioplasty to assess the effectiveness and safety of the robotic-assisted CorPath system
High-sensitive test could more accurately predict risk of myocardial infarction in women
A new high-sensitive troponin test could be used to improve the diagnosis and prognosis of patients presenting with symptoms of a myocardial infarction, and it could be particularly beneficial for women.
New arterial cannula for TandemHeart temporary circulatory support launched
The Protek17, which is an arterial cannula for use with the TandemHeart temporary circulatory support platform, is now available on the market. It has been designed to improve patient safety and ease of use.
First patient enrolled in US trial of Direct Flow Medical’s TAVI valve
The first patient has been enrolled in the US SALUS clinical trial, which is evaluating Direct Flow Medical's transcatheter aortic valve implantation (TAVI) device.
First two implantations of JenaValve transapical TAVI system in Canada successfully completed
The first two implantations of the second-generation transapical JenaValve transcatheter aortic valve implantation system to be performed outside of Europe have been successfully completed in Canada.
CE mark for TAVI cerebral protection device
Keystone Heart's Triguard, a cerebral protection device for use in transcatheter aortic valve implantation (TAVI) procedures, has received the CE mark.
No to dabigatran for mechanical heart valves
The RE-ALIGN study shows that dabigatran (Pradaxa, Boehringer Ingelheim) is associated with increased thromboembolic events and bleeding complications, compared with warfarin, in patients with mechanical heart valves.
Review pre-treatment strategies in NSTE-ACS patients
The negative results of the ACCOAST study may mean that the strategy of routinely pre-treating patients with non-ST-segment elevation acute coronary syndromes with a P2Y12 antagonist prior to an invasive procedure needs to be revised.
The future of patent foramen ovale closure after the RESPECT and PC trials
Two studies RESPECT (Randomized evaluation of recurrent stroke comparing PFO closure to establish current standard of care treatment) and the PC Trial failed to show that percutaneous closure of patent foramen ovale (PFO) significantly reduces the risk of recurrent stroke. Bernhard Meier reviews the future role of PFO closure in the light of these studies.
Performing TAVI in patients with carotid artery disease
TAVI is mostly performed via a transfemoral or a transapical approach. A relevant number of patients with severe aortic stenosis also suffer from symptomatic carotid artery disease. Rainer Moosdorf describes a new combined surgical approach.
New study will test personalised antiplatelet therapy
Roche has started a new study TROPICAL-ACS that will evaluate the benefit of personalised antiplatelet therapy in patients who have acute coronary syndrome treated with percutaneous coronary intervention.
New closure system for TAVI and mitral valve surgery approved
Apica Cardiovascular has received the CE mark for its platform Access, Stabilisation, and Closure (ASC) system, which allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart.
Cangrelor reduces angiographic complications compared with clopidogrel
Data presented at the European Society of Cardiology annual congress (ESC; 31 August–4 September, Amsterdam, The Netherlands) shows that intravenous cangrelor is associated with a significant reduction in angiographic complications compared with oral clopidogrel.
Orsiro stent now available in lengths up to 40mm
Biotronik has launched new 35mm and 40mm versions of its Orsiro hybrid sirolimus-eluting stent, which has a biodegradable polymer matrix.
CE mark for new version of Vivid E9 cardiovascular ultrasound system
The CE mark has been awarded to a new version of GE Healthcare's Vivid E9 cardiovascular ultrasound system. The new version features XDclear technology, which is designed to enhance image quality in 2D, 4D, colour and doppler.
Philips can now market its Epiq premium ultrasound system
The FDA has given Philips approval to market its Epiq premium ultrasound system, which uses nSIGHT technology and anatomical intelligence to address complicated imaging needs of an ageing global population.
Next-generation of EnligHTN approved in Europe
St Jude Medical has announced that the next generation of its EngliHTN renal denervation system has received the CE mark. The company reports that compared with the original system, the new system reduces total ablation time by 80%.
HeartWare can start enrolment for additional patient cohort in pivotal study
The FDA has given HeartWare an investigational device exemption (IDE) supplement to allow the company to start enrolment in an additional patient cohort for its ENDURANCE study, which is evaluating the company's ventricular assist system as a destination therapy for heart failure patients.
Resistant hypertension study crosses halfway point
Rox Medical has announced that, with the enrolment of the first German patient, it has crossed the halfway point of its CONTROL-HTN trial an international, multicentre, randomised controlled hypertension trial of its Rox Flow procedure.
CE mark for device that repairs heart defects
Allied Healthcare Group has announced the CE mark approval and launch of its CardioCel device, which can be used for the repair and reconstruction of heart defects in both children and adults.
Pick up your free copy of Cardiovascular News at ESC
Free copies of the latest issue of Cardiovascular News will be at available at the European Society of Cardiology's annual meeting (ESC; 31 August–4 September, Amsterdam, The Netherlands) in the Central Village in the congress centre (Amsterdam RAI).
Overlapping everolimus-eluting stents not associated with poorer outcomes
According to a new study in EuroIntervention, unlike overlapping sirolimus-eluting stents, overlapping everolimus-eluting stents are not associated with poorer outcomes compared with non-overlapping drug-eluting stents.
Women are at greater risk of cancer after cardiac imaging and procedures
A new study has found that compared with men, women have an increased risk of incident cancer after cardiac imaging and procedures. However, their absolute risk is low and the benefits of these interventions outweigh the risks.
Parachute ventricular partitioning device successfully used in Asia
CardioKinetix has announced its Parachute ventricular partitioning device has been used in Asia for the first time, with four patients being successfully treated with the novel catheter-based device in Kuala Lumpur, Malaysia.
Incidence of rare coronary obstruction carries high acute and late mortality rates but is preventable
According to the results of a large multicentre registry, patients who undergo TAVI can suffer a rare and life-threatening complication coronary obstruction. The registry investigated the main baseline, procedural characteristics and management of clinical outcomes in patients who experienced coronary obstruction.
Six to 12 months is the right timeframe for dual antiplatelet therapy
During the Great Debate at this year's EuroPCR (21–24 May, Paris, France), leading experts in interventional cardiology discussed the use of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The key issues raised were the optimum duration of DAPT with second-generation, drug-eluting stents and the use of new, more potent, antiplatelets.
First patients enrolled in REMEDEE registry to evaluate Combo dual-therapy stent
Patient enrolment has been initiated in a post-market registry for the Combo dual-therapy stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicentre, all-comers REMEDEE registry is expected to enrol 1,000 patients.
Medtronic acquires Cardiocom
Medtronic announced on 12 August the closing of the acquisition of Cardiocom, in an all-cash transaction valued at US$200 million. Medtronic expects the net impact from this transaction to be neutral to fiscal year 2014 earnings.
Former US president’s procedure “another example of the inappropriate stenting trend in the USA”
Former US president George W Bush's recent heart stent operation will further increase the popularity of what is often an unnecessary and wasteful procedure, says an analyst with research and consulting firm GlobalData.
Gore prevails in heart device patent infringement suit
Gore has announced a favourable ruling involving the Gore Helex Septal Occluder. Judge Joan Ericksen of the US District Court for the District of Minnesota, USA, ruled on 23 July in Gore's favour that the Gore Helex Septal Occluder does not infringe the asserted claims of AGA Medical US patent and granted Gore's request for summary judgement of non-infringement.
New funding for research may lead to better heart failure treatments
Researchers at the University of Reading, UK, have been awarded funding of £114,500 by Heart Research UK to investigate new ways of treating heart failure and factors affecting cell division, survival and death.
Four patients successfully treated with ACURATE TA and ACURATE TF devices
Symetis has announced the first-time implantation of its ACURATE TA and ACURATE TF transcatheter aortic valve implantation (TAVI) devices in Japan.
Using a hybrid OR for TAVI: A procedural overview
Timothy C Ball, an interventional cardiologist at Carilion Roanoke Memorial Hospital, Roanoke, USA, speaks about using a hybrid operating room and explains a transcatheter aortic valve implantation (TAVI) procedure.
Non-access site bleeding is a stronger predictor of mortality than access site bleeding
A new study indicates that while both access site bleeding and non-access site bleeding after PCI are independently associated with an increased risk of one-year mortality, non-access site bleeding is a stronger correlate of mortality than access site bleeding
Renal denervation is safe and effective for moderate resistant hypertension
The first prospective pilot study of renal denervation in patients with moderate treatment-resistant hypertension indicates that the intervention is safe and effective in this patient population.
CE mark for longer lengths of Cre8
CID has announced that it has received the CE mark for longer lengths 31mm in small sizes and 38mm for the entire product range of its polymer-free, drug-eluting stent, Cre8.
Boston Scientific launches new coronary imaging catheter in Europe and USA
Boston Scientific has announced that it has launched a new imaging coronary imaging catheter, the OptiCross, in Europe and in the USA.
“Our goal is to use the least invasive approach” for mitral valve surgery, surgeons say
Marc Gillinov and Stephanie Mick, both of the Cleveland Clinic, Cleveland, USA, discuss mitral valve surgery and the options available to patients, including robot-assisted mitral valve repair.
Sorin to manufacture components for TAVI valve
Sorin has announced that its Vancouver site will manufacture components of the Lotus TAVI valve.
Robotic-assisted stent placement device used for first time
Corindus Vascular Robotics has announced that for the first time, its CorPath robotic angioplasty device has been used in a PCI procedure.
New range of PCI guidewires launched
Biotronik has launched the Galeo Pro, which is a new range of percutaneous coronary intervention (PCI) guidewires
German court finds Medtronic infringes Edward Lifesciences’ patent
A court in Germany has found that Medtronic's CoreValve infringes Edward Lifesciences' Spenser patent.
Thoratec acquires DuraHeart II ventricular assist system
Thoratec Corporation said, in a press release on 1 July, that it has acquired the DuraHeart II ventricular assist system from Terumo for an upfront cash payment of US$13 million and potential future milestone payments, based on regulatory approvals and product sales, of up to US$43.5 million.
Boston Scientific launches new guide extension catheter in the USA and Europe
On the 12 July, Boston Scientific announced it had received US Food and Drug Administration (FDA) 510(k) clearance and CE mark approval for the Guidezilla guide extension catheter and has launched the device in the USA and Europe.
CryoLife receives FDA premarket approval for minimally invasive TMR laser fibre optic delivery system
CryoLife announced on 10 July that it has received US Food and Drug Administration (FDA) premarket approval for its new Sologrip minimally invasive laser fibre-optic delivery system.
Self-apposing stent approved for additional coronary interventions
Stentys has announced that it has received approval to expand the CE mark indications of its self-apposing coronary stent.
High procedural success rate with JenaValve in real-world data
JenaValve Technology released the first results of its long-term performance and safety in patients with severe aortic stenosis (JUPITER) registry at EuroPCR (21–24 May, Paris, France), demonstrating high procedural success rates and excellent clinical outcomes.
Abbott announces approval of next-generation drug-eluting stent system in Japan
Abbott has announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the Xience Xpedition everolimus-eluting coronary stent system for the treatment of coronary artery disease.
NICE publishes guideline for treating people with acute heart attack
A new NICE guideline aims to improve the outcomes for STEMI patients. The guideline includes recommendations on coronary angiography, primary PCI and reperfusion therapy.
TAVI in mitral valve surgery patients is feasible
A small observational study indicates that a self-expanding transcatheter aortic valve implantation (TAVI) device (CoreValve, Medtronic) could potentially be used to treat severe aortic stenosis in patients who have previously undergone mitral valve surgery.
Cardiogenic shock is strongest predictor of stent thrombosis
According to an all-comers registry published in EuroIntervention and presented at EuroPCR (21–24 May, Paris, France), cardiogenic shock is the strongest predictor of stent thrombosis following percutaneous coronary intervention.
Optimising care through the heart team approach
David Holmes (Mayo Clinic, Cardiovascular Diseases and Internal Medicine, Rochester, USA) spoke to Cardiovascular News about the goals of a heart team approach in interventional cardiology
Study shows sustained improvement with Revivent Myocardial Anchoring System
A study published in the European Journal of Cardio-Thoracic Surgery indicated that 39.6% of patients who received the Revivent Myocardial Anchoring System had a sustained improvement in heart function at one year.
Middle Peak Medical raises $8.5M for novel mitral valve technology
Middle Peak Medical, which is planning to commercialise a novel technology for treating mitral valve disease, has announced that it has US$8.5M in a Series A financing
Mitral valve repair in severe mitral regurgitation: An interventional cardiologist’s perspective
Sachin Goel and Samir Kapadia review the different interventional methods of managing mitral regurgitation
New imaging technique could improve stenting of bifurcations lesions
StentBoost, a new imaging technique that enhances stent fluoroscopic visibility, is a simple and quick method that offers several advantages during percutaneous coronary intervention in patients with bifurcation lesions
Black patients undergo aortic valve replacement significantly less frequently than white patients
Despite white patients and black patients having similar survival rates following aortic valve replacement for aortic stenosis, black patients undergo the surgery significantly less frequently.
BIBA Medical launches international TAVI monitor
BIBA Medical has announced that it has launched an international TAVI monitor, which is an extension of the company's current TAVI monitor.
Promising results for Bendavia presented at ESC Heart Failure meeting
According to several studies presented at the European Society of Cardiology Heart Failure Congress (25–28 May, Lisborn, Portugal), the use of the novel compound Bendavia is associated with improved cardiac function, preserved viable myocardium and increased survival in systolic and diastolic heart failure models.
New valve-in-valve training App available
A new App, for both Mac and Android devices, that provides training on valve-in-valve procedures using transcatheter valves has been launched.
Data show patients on low anticoagulant therapy do well on On-X prosthetic heart valve
Results from the On-X Heart Valve study presented at the Society for Heart Valve Disease 7th Biennial Congress (22–25 June, Venice, Italy) show that patients on low anticoagulation therapy do well with the On-X prosthetic heart valve.
Fixed-dose treatment Sevikar superior to combination of perindopril and amlodipine
Data from the SEVITENSION study indicate the fixed-dose treatment Sevikar (olmesartan/amlodipine) is superior to perindopril in combination with amlodipine in reducing central blood pressure.
FDA approves labelling change for balloon catheter
The FDA has given approval to AngioScore to change the instructions for use for its AngioSculpt scoring balloon catheter.
FDA clears Cordis’s Adroit guiding catheter
The FDA has approved Cordis's Adroit 6F guiding catheter for use in various coronary anatomies.
Joint hypertension guidelines claim lifestyle factors are partly to blame for increase in hypertension
The joint 2013 European Society of Hypertension/European Society of Cardiology guidelines for the management of arterial hypertension state that lifestyle changes are the "cornerstone" to preventing hypertension.
New data demonstrate long-term durability of Perimount aortic valve
According to data released by Edwards Lifesciences, the Perimount aortic valve is associated with a long-term durability in patients aged 60 or younger at the time of operation.
Baseline data for extreme risk patients in CoreValve trial revealed
Medtronic has released the baseline data for the extreme risk patients enrolled in its CoreValve US pivotal trial.
Transulnar approach should not be used as default strategy for coronary procedures
A study has found that the transulnar approach for coronary procedures is associated with significantly higher crossover rates compared with the transradial approach.
Stress cardiac MRI has excellent prognostic value
A new study indicates the cardiac magnetic resonance imaging (MRI) stress testing could be used to predict the risk of cardiovascular death and myocardial infarction in patients with known or suspected coronary artery disease.
Key factors for valve-in-valve procedural success
Danny Dvir provides a short summary of practical recommendations that can improve procedural success during valve-in-valve procedures
Ambulatory blood pressure monitoring technologies to be featured at ESH 2013
SunTech Medical, in a press release, announced they will be showcasing their ambulatory blood pressure monitoring system for 24 hour management and analysis of patient blood pressure data.
Biotronik announces positive long-term safety outcomes from BIOSOLVE-I study
Results from the BIOSOLVE-I study that were presented at the EuroPCR have demonstrated the excellent safety profile of the DREAMS drug-eluting absorbable metal scaffold, according to a company release.
Surgery master class offers the opportunity to receive bypass surgery technique training
An Oxford-based (UK) master class is available for trainee surgeons to receive training from experience cardiothroacic surgeons and share their own experiences. The class is funded by the Heart UK.
Surgeons complete clinical trial on novel two-part heart valve
Cardiac surgeons in Germany, Austria and Poland have successfully completed implants and patient enrolment in the VITAL-2 clinical trial for the Vitality Heart Valve System (ValveXchange), according to a company release.
Abbott initiates randomised trial in Japan to evaluate bioresorbable vascular scaffold
According to the company the trial will examine the "dissolving" heart device compared to Abbott's drug-eluting stents in patients with coronary artery disease in Japan.
Positive outcomes with MitraClip in two real-world studies
According to two European postmarket studies, Abbott Vascular's MitraClip is associated with positive outcomes in patients with mitral regurgitation.
Toshiba’s Infinix DP-i X-ray system now compatible with its CAT-880B hybrid table
Toshiba has announced that its Infinix DP-i X-ray system is now compatible with its CAT-880B hybrid table for hybrid and transcatheter aortic valve implantation (TAVI) procedures.
Biosensors will market drug-eluting balloons manufactured by Eurocor
Biosensors has entered into a licensing agreement with Eurocor on the company’s drug-eluting balloons. The first part of the agreement states that Bionsensors will market and sell drug-eluting balloons manufactured by Eurocor under its own brand.
Novel drug reduces plasma levels of triglycerides by almost 100%
In a study presented at the European Atherosclerosis Society annual meeting (2-5 June, Lyon, France), the first-in-class lipoprotein lipase activator LP071 was shown to reduce plasma levels of triglycerides by almost 100% and more than doubled plasma levels of high-density lipoprotein cholesterol in an animal model.
DES with biodegradable polymer is non-inferior to durable polymer DES
A late-breaking trial, presented at EuroPCR (21–24 May, Paris, France), indicates that Biotronik's Orsiro a drug-eluting stent with a biodegradable polymer was non-inferior to Abbott Vascular's Xience Prime, a drug-eluting stent with a durable polymer, in terms of in-stent late lumen loss.
Superiority of bivalirudin over heparin questioned
Results from a large observational study, presented at EuroPCR (21–24 May, Paris, France) suggest that in the absence of GP IIb/IIIa receptor inhibitors, bivalirudin does not improve outcome compared with heparin in patients with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.
Three- and six-month data for Surround Sound renal denervation system presented at EuroPCR
Kona Medical presented three- and six-month data from its WAVE I study of its Surround Sound renal denervation system in a late-breaking trial session at EuroPCR (21-24 May, Paris, France).
ADVISE II confirms clinical usefulness of iFR/FFR hybrid approach
A late-breaking study, ADVISE (Adenosine vasodilator independent stenosis evaluation) II, presented at EuroPCR (21–24 May, Paris, France) indicates that the combination of instant wave-free ratio (iFR) and fractional flow reserve (FFR) is a useful clinical approach for assessing coronary lesions.
CE mark for Combo dual therapy stent
After receiving the CE mark for its dual therapy Combo stent, OrbusNeich has launched the device onto to the European market.
Registry confirms Neovasc Reducer improves cardiovascular parameters in refractory angina patients
Registry data presented at EuroPCR (21–24 May, Paris, France) shows the Neovasc Reducer, a novel percutaneous device that is CE marked for the treatment of refractory angina, to improve cardiovascular parameters in refractory angina patients.
Maquet buys LAAx and its TigerPaw system II occlusion device
Maquet has announced it has acquired the company LAAx and its TigerPaw system II occlusion device.
Axxess self-expanding stent is safe and effective at five years
Long-term data from the DIVERGE study, presented at EuroPCR (21–24 May, Paris, France), shows that the Axxess drug-eluting stent is associated with safe and effective treatment of complex coronary lesions.
Demonstr8 shows Cre8 drug-eluting stent is non-inferior in terms of strut coverage to a bare metal stent
During a late-breaking trial session at EuroPCR (21–24 May, Paris, France), principal investigator Francesco Prati presented the results of the Demonstr8 study, which showed the Cre8 drug-eluting stent to be non-inferior to an Abbott Vascular bare metal stent with a high statistically significant difference (RUTTS Score <30%; 99.75% Cre8 vs.99.55% bare metal stent; p<0.0001).
Morton Kern
Morton Kern is chief of cardiology at the Long Beach Veterans Administration Hospital, Long Beach, USA, and is also associate chief of Cardiology at University of California, Irvine, Orange California, USA. He is the co-chair of the Society for Cardiovascular Angiography and Interventions' annual meeting (SCAI; 8–11 May 2013, Orlando, Florida). He talked to Cardiovascular News about his career and his achievements
Huge progress needs to be made before bioresorbable stents can replace permanent stents
Renu Virmani, medical director, CVPath Institute, Gaithersburg, USA, spoke to Cardiovascular News about bioresorbable stents and their potential impact on the future management of coronary artery disease.
Transradial access will probably become the default primary PCI strategy
Daniel Steinberg reviews the transradial approach in primary percutaneous coronary intervention (PCI) and looks at why the USA has been reluctant to adopt the approach despite it reducing access site and bleeding complications compared with the transfemoral approach
Significant and sustained blood pressure reduction with Vessix renal denervation system
Interim data from the REDUCE-HTN study, which was presented at EuroPCR (21–24 May, Paris, France), indicates that the Vessix renal denervation system (Boston Scientific) is associated with a significant and sustained reduction in blood pressure.
Medtronic’s Resolute Stent delivers strong long-term results
At EuroPCR 2013 in Paris, France (21–24 May), three separate analyses have addressed one of the most common clinical challenges in the treatment of complex coronary artery disease and showed that the the Resolute drug-eluting stent from Medtronic has performed strongly in coronary bifurcation lesions over the long term.
Meta-analysis presented at EuroPCR substantiate potential of breakthrough treatment for heart failure patients
CardioKinetix has announced positive clinical data that showed positive results for patients treated with minimally invasive structural heart device for heart failure.
IN.PACT Falcon drug-eluting balloon yields positive outcomes
Presented at EuroPCR, the one-year results from BELLO study showed durability following treatment of de novo lesions with the novel angioplasty device.
First results from DESolve Nx trial show low rate of late lumen loss with bioresorbable DESolve device
The DESolve Nx trial treated target lesions in 126 patients with single de novo coronary artery lesions with the DESolve device. Results showed the primary endpoint of in-stent late lumen loss was 0.21mm (+0.34) at six months.
Post-approval TAVI registry shows high rates of device success at one year
One-year results from SOURCE XT, one of the largest, post-approval transcatheter aortic valve implantation (TAVI) registries (according to a EuroPCR press release) has reported good clinical outcomes in clinical practice.
Late-breaking ORBIT II coronary data to be presented at EuroPCR
The ORBIT II trial evaluating safety and effectiveness of the orbital atherectomy system in treating calcified coronary lesions is expected to presented as late-breaking data at EuroPCR (21–24 May, Paris, France).
New registry data confirms safety of BioMatrix drug-eluting stent family in more than 5000 patients
Of those studied, only 4.3% were reported as experiencing a primary endpoint event in the e-BioMatrix study.
Abbott announces CE mark for world’s longest coronary drug-eluting stent
According to Abbott, Xience Xpedition is the world's longest coronary drug-eluting stent and has received the CE mark.
“TAVI with CoreValve represents good value for healthcare spending”
According to a presentation at EuroPCR, "real world" ADVANCE study has confirmed that using CoreValve has good economic value in patients unable to undergo surgery.
Six-month results of the MASTER trial presented at EuroPCR
According to a press release clinical evidence supporting the benefits of using the MGuard EPS in STEMI patients continues to grow and a presentation at EuroPCR meeting added important new data underlining the protective benefits of MGuard six months post procedure.
Transcatheter aortic valve system demonstrates excellent 30-day outcomes
Direct Flow Medical has announced that it met its primary endpoint in the fully-enrolled, 100-patient DISCOVER CE mark trial by achieving 99% freedom from all-cause mortality at 30 days.
High procedural success rate with JenaValve in real-world population
JenaValve Technology released the first results of its long-term performance and safety in
patients with severe aortic stenosis (JUPITER) registry at EuroPCR (21–24 May, Paris, France), demonstrating high procedural success rates and excellent clinical outcomes.
Cardiologists reduce X-ray radiation by 50% in cardiac catheterisation procedures
According to a clinical study and Philips, using the AlluraClarity live guidance system, a 50% reduction in X-ray dose could be achieved without any loss in image quality.
Live 3D TEE capability can increase visualisation for intracardiac repair
Philips announced that their CX50 xMATRIX now has 2D intracardiac echo capability. The CX50 xMATRIX with available Live 3D TEE and ICE is expected to be shown in Paris, France, at EuroPCR, 21–24 May.
Delayed coronary artery healing after implantation of drug-eluting stents is a concern
According to an online survey of 141 interventional cardiologists worldwide, the use of drug-eluting stents and the delay to healing is a concern.
Clinical safety and efficacy of renal denervation with Symplicity system confirmed by the global SYMPLICTY registry
According to a Medtronic press release, data from the global SYMPLICITY registry showed renal denervation with the Symplicity system met performance expectations in a real-world setting.
CircuLite receives approval for CE mark trial for Synergy IC circulatory support system
Circulite has announced it has received CE mark approval to conduct a multicentre trial on the Synergy IC circulatory support system. An abstract on the system is expected to be presented at EuroPCR (21–24 May, Paris, France).
Biosensors receives CE mark approval for BioMatrix NeoFlex
On the 20 May 2013, Biosensors International announced it has received CE mark approval for its BioMatrix NeoFlex, the latest addition to the BioMatrix family of drug-eluting stents.
Late-breaking Demonstr8 trial results to be presented at EuroPCR
A symposiumat EuroPCR (21–24 May, Paris, France) is expected to discussed the Cre8 stent. According to a company release, this will include presentations from clinicians on Cre8 trial data, followed by a panel and audience discussion.
First clinical research on the frequency and composition of embolic debris captured during TAVI published
Published in Circulation, new research examining the frequency and composition of embolic debris captured in TAVI, has found that in a 40 patient series, there were visible debris in 75% of patients when using the Claret Montage Dual Filter System.
CE mark approval for Metronic’s Export Advance aspiration catheter
Medtronic announced that its Export Advance aspiration catheter recently received the CE mark and will soon be launched in Europe and other international markets.
Genous stent associated with lower restenosis rate compared to bare metal stents
Data of the randomised JACK-EPC trial showed that the Genous stent had a significantly lower rate of binary restenosis compared to bare metal stents in acute coronary syndrome patients. The results have been published in Minerva Cardioangiologica.
Poor economy may be cause of underuse of TAVI in Europe
A new study suggests that transcatheter aortic valve implantation (TAVI) devices are under used in Europe, and that this under use is associated with economic status and reimbursement strategies.
New risk score could predict risk of bleeding after PCI
A new risk score, developed using data from the RISK-PCI study, could be used to identify which patients are at high risk of bleeding after undergoing a percutaneous coronary intervention (PCI) procedure.
FDA gives conditionally approval for IDE trial of Sorin’s Perceval S sutureless aortic valve
Sorin has announced that it has received conditional approval from the Food and Drug Administration (FDA) to conduct an investigational device exemption (IDE) study of its Perceval S Sutureless aortic valve.
FDA approves trial of Desyne Nx novolimus-eluting stent
Elixir Medical has announced it has received Food and Drug Administration (FDA) approval to start its EXCELLA clinical trial of its Desyne Nx novolimus-eluting stent system.
Enrolment completed for low-risk aortic and mitral patients in prosthetic heart valve study
On-X Life Technologies has announced that it has completed enrolment for low-risk aortic valve and mitral valve patient groups in its Prospective randomised On-X Valve anticoagulation trial (PROACT).
Black and Hispanic patients have worst outcomes after PCI
A study published in Circulation indicates that compared with white patients, black and Hispanic patients have worse outcomes following percutaneous coronary intervention (PCI).
REMEDEE study published in JACC: Cardiovascular Interventions
The REMEDEE study, which showed that OrbusNeich's Combo dual therapy stent is effective at controlling neo-intimal proliferation, has been published in the journal JACC: Cardiovascular Interventions.
Being mentally vulnerable significantly increases risk of cardiovascular disease
According to a study presented at EuroPRevent 2013, mental vulnerability is associated with a significantly increased risk of fatal and non-fatal cardiovascular disease independently of classical risk factors.
MediLive realises innovative medical lessons in 3D
MediLive has developed a 3D training series for both students and medical professionals.
Natec Medical is now able to market Tamarin Blue and Filao RX in Canada
In March, Natec Medical received a licence to market its Tamarin Blue and Filao RX in Canada
FDA 510(k) clearance and CE mark for AIR- BAND radial compression device
Maquet has received both FDA approval and CE mark approval for its AIR-BAND radial compression device.
C-CURE study published in the Journal of the American College of Cardiology
Results from the C-CURE study, which reviews the use of C3BS-CQR-1 in patients with chronic heart failure, have been published in the Journal of the American College of Cardiology.
Post-market study confirms high procedural success rate for Acurate TA
Symetis has announced that a post-market study has confirmed that its transcatheter aortic valve implantation (TAVI) Acurate TA device is associated with a high procedural success rate.
CE mark for fourth generation Maya coronary balloon catheter
Arthesys has announced that it has received the CE mark for its fourth generation Maya coronary balloon catheter.
MIRA-iCS Retractor system launched on to USA market
Maquet Medical Systems has announced that it has launched the MIRA-iCS Retractor system, for use during minimally invasive revascularisation procedures, on to the USA market.
FDA approves full expansion of INNOVATE-HF study
BioControl Medical has announced that the FDA has approved full expansion of the INNOVATE-HF study, which is investigating BioControl Medical's CardioFit device for vagal nerve stimulation.
High-intensity focused ultrasound may be an alternative renal denervation approach
A new study, published ahead of print in the Journal of the American College of Cardiology, indicates that renal denervation delivered through extracorpeal high-intensity focused ultrasound may be an alternative approach to managing resistant hypertension.
Left ventricular assist devices do not improve sexual function
A study published ahead of print in the Journal of the American College of Cardiology indicates that following implantation of a left ventricular assist device, sexual function does not improve and may even worsen.
Reducing periprocedural complications is key for the future use of TAVI in lower-risk patients
Max Baghai and Olaf Wendler review the current data for TAVI procedures and discuss how the complications of these procedures can be minimised.
New quality standard calls for person-centred care
The UK's National Institute for Health and Clinical Excellence (NICE) has launched a new quality standard for hypertension, which states that person-centred care is vital in the management of the condition.
Positive outcomes for Promus Element in Platinum China study
Boston Scientific has announced that the Platinum China study, which was presented at China Interventional Therapeutics (20–23 March, Beijing, China), indicated that the Promus Element stent is associated with a low rate of stent thrombosis at nine months.
600th patient recruited to pivotal heart attack study
NeuroVive has announced the 600th patient has been recruited to its pivotal Phase III European, multicentre trial (CIRCUS trial), which is assessing CicloMulsion.
EMEA recommend rivaroxaban is approved for ACS patients
Bayer has announced that the European Medicines Agency has recommended that its drug rivaroxaban (Xarelto) be approved for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS).
FDA votes that the benefits of MitraClip outweigh the risks
The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted five to three that the benefits of Abbott Vascular's MitraClip outweigh its risks.
Trifecta valve closely resembles haemodynamic performance of natural valve
A new study, published ahead-of-print in the Journal of Thoracic and Cardiovascular Surgery, suggests that the Trifecta aortic valve has a similar haemodynamic performance to that of a healthy aortic valve.
ORBIT II trial meets its primary endpoint
At ACC, data from the ORBIT II study showed that patients treated with the Orbital atherectomy system (Cardiovascular Systems) were associated with an 89.8% freedom from major adverse cardiovascular events rate.
First-in-world implantation of next-generation Promus Premier stent
For the first time, the Promus Premier everolimus-eluting coronary stent has been implanted into patients in Ireland and in the Netherlands.
Philips launches portfolio at the American College of Cardiology Scientific Session 2013
At the American College of Cardiology Scientific Session (ACC.13), Philips introduced its portfolio of cardiology solutions. This included the IntelliSpace ECG, the ST80i Stress Testing System, the EchoNavigator, and the Corindus CorPath 200 System.
Toshiba demonstrates the Aquilion ONE ViSION system at the American College of Cardiology’s Annual Meeting 2013
According to the company, the Aquilion ONE ViSION can image the heart in one rotation with a low dose of radiation when used in conjuction with the company's Vital Images' CT Myocardial Analysis software. A trial conducted by the National Institutes of Health confirms in 107 patients that the system's average radiation dose was low.
Positive three-year MACE results for bioresorbable scaffold
Results presented at the ACC for the bioresorbable vascular scaffold Absorb showed that the device was associated with a major adverse cardiovascular events rate of 10% at three years.
Low rate of mortality observed with Self-Apposing stent
One-year data from APPOSITION III, which is assessing the long-term performance of the Stentys Self-Apposing stent, indicated that the device is associated with a very low rate of mortality (2%).
Sustained drop in blood pressure observed with Symplicity renal denervation system
Two-year data for the Symplicity renal denervation system showed that the intervention was associated with a sustained significant drop in blood pressure.
Cangrelor significantly reduces ischaemic events compared with clopidogrel
New study, CHAMPION PHOENIX, indicates that cangrelor significantly reduces the rate of ischaemic events including stent thrombosis compared with clopidogrel in patients undergoing urgent or elective percutaneous coronary intervention.
Transcatheter aortic valve still works after three years in high-risk patients
The midtem results from cohort A of the PARTNER study indicate that, after three years, the Sapien transcatheter aortic valve is still structurally intact and that transcatheter aortic valve implantation continues to be comparable to surgery in high-risk patients.
Knowing the long-term benefits of renal denervation is a priority
Despite a range of safe and effective antihypertensive therapies, hypertension is still a challenging condition to control only a small percentage of hypertensive patients achieve adequate blood pressure control. Intravascular renal denervation may be beneficial in treating resistant hypertension, but there are gaps in the evidence base. Jan Staessen reviews the current research for this intervention and the priorities for future research
Promus Element Platinum Chromium Stent demonstrates continued low event rates through three years
At the ACC 2013 sessions, Ian Meredith, Melbourne, Australia, reported clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the Promus Element Coronary Stent System (Boston Scientific) to the Xience V Everolimus-Eluting Coronary Stent System (Abbott).
Gene expression test influences patient management decision in women with suspected obstructive coronary artery disease
Results from the IMPACT trial, presented at ACC 2013, have found that cardiologists changed their diagnostic testing strategy of coronary artery disease in 60% of female patients following Corus CAD testing.
Direct Flow Medical Transcatheter Aortic Valve System demonstrates excellent six-month outcomes in DISCOVER trial
Results of the DISCOVER trial, presented at ACC 2013, have shown that patients treated with the Direct Flow Medical Transcatheter Aortic Valve System (Direct Flow Medical) achieved excellent survivability and sustained haemodynamic improvements with minimal occurrence of aortic regurgitation at six months.
St Jude Medical launches its three-dimensional vessel reconstruction technology in Japan
The Ilumien Optis system combines fractional flow reverse and intravascular optical coherence technology (OCT) to help with stent placement and has been launched by St Jude Medical in Japan.
TITAN II completes patient enrolment
The study is aimed to evaluate an enhanced version of the Carillon Mitral Contour System (Cardiac Dimensions), a minimally-invasive therapy designed to treat heart failure patients suffering from functional mitral regurgitation.
30-day mortality is significantly lower with MitraClip
New data for the MitraClip system indicates that the device is associated with a significantly lower rate of 30-day mortality compared with open surgery.
Interrupting dual antiplatelet therapy one month after Resolute stent implantation does not increase safety risk
Data from the Global RESOLUTE clinical programme indicates that interrupting dual antiplatelet therapy one month after a patient is implanted with a Resolute drug-eluting stent is not associated with an increased safety risk.
Philips announces FDA clearance for its EchoNavigator live image-guidance tool
Royal Philips Electronics has announced that it has received 510(k) clearance from the FDA to market its EchoNavigator live image-guidance tool.
First patients enrolled in CONTROL-HTN hypertension trial at two Irish private hospitals
Rox Medical has announced that the first patients in Ireland have been enrolled in the in CONTROL-HTN hypertension at Beaumont and Mater private hospitals.
CircuLite receives conditional FDA approval for IDE trial
CircuLite has announced it has received conditional FDA approval for an investigational device exemption study of its Synergy circulation support system.
FDA approves Artis Q and Artis Q.zen angiography system families
Siemens Healthcare has announced that the FDA has approved its Artis Q and Artis Q.zen angiography system families.
Medtronic receives approval to update Resolute Integrity DAPT labelling
Medtronic has been given the go-ahead to update the dual antiplatelet therapy CE mark labelling for its Resolute Integrity drug-eluting stent.
CE mark for Engager TAVI system
Medtronic has received the CE mark for its Engager transcatheter aortic valve implantation system, which delivers the Engager valve transapically.
Clinical protocol for COSIRA study published in peer-reviewed journal
Neovasc has announced that the clinical protocol for its COSIRA study, which assesses the company's novel percutaneous device for reducing refractory angina, has been published in a peer-reviewed journal.
Medtronic gains first FDA approval to conduct early feasibility medical device study
Medtronic has announced it has received FDA approval to conduct an early feasibility study of its native outflow tract transcatheter pulmonary valve.
SynCardia’s 50cc total artificial heart receives two HUD designations from the FDA
The FDA has approved two Humanitarian Use Device (HUD) designations for the new SynCardia's 50cc total artificial heart
Microvascular resistance increases after angioplasty in NSTEMI patients
A new study indicates that microvascular resistance, contrary to previous studies, increases after percutaneous coronary intervention and this increase is not linked to increasing epicardial stenosis.
Three-year Orbit I coronary data presented at CRT 2013
Cardiovascular Systems presented three-year data for its orbital atherectomy system at CRT 2013 (23–26 February 2013, Washington, USA).
TAVI is feasible in non-surgical patients with pure native aortic valve regurgitation
According to a new study, transcatheter aortic valve implantation is feasible in non-surgical patients with severe native aortic valve regurgitation without stenosis.
Optimising the management of older patients with STEMI
Stefano Savonitto, director, Cardiology Division, Arcispedale S Maria Nuova, Reggio Emilia, Italy, talked to Cardiovascular News about treating older patients with STEMI. He spoke about this topic at JIM.
Stefan D Anker
Stefan D Anker is the 2012–14 president of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). He has been credited with establishing cachexia as an independent prognostic factor for cardiovascular illness, and he has shown that iron deficiency is a valid therapeutic target in heart failure. He spoke to Cardiovascular News about his career, research in heart failure and his goals during his HFA presidency tenure.
Two new TAVI patents for Direct Flow Medical
Direct Flow Medical has been awarded two patents, one from the US Patent and Trademark Office and one from the Japanese Patent Office, for its transcatheter aortic valve implantation system.
FDA approves longer lengths of Resolute Integrity
The FDA has approved the 34mm and 38mm lengths of Medtronic's Resolute Integrity drug-eluting coronary stent.
Study to investigate if renal denervation can provide benefits beyond lowering blood pressure
St Jude Medical has announced it has initiated a study to evaluate whether the renal denervation can lower the risk of major cardiovascular events as well as lower blood pressure
Corus CAD test outperforms myocardial perfusion imaging in new study
According to a study published in Circulation: Cardiovascular Genetics, the Corus CAD test outperforms myocardial perfusion imaging in overall diagnostic accuracy for obstructive coronary artery disease.
ReCor Medical starts post-marketing study of its ultrasound-based renal denervation system
ReCor Medical has announced that it has begun ACHIEVE a post-marketing study of its next-generation, ultrasound-based renal denervation system, Paradise.
FDA gives IDE approval to Society of Thoracic Surgeons and American College of Cardiology for TAVI study
The IDE study is designed to explore alternative access routes with transcatheter aortic valve implantation (TAVI). It is believed to be a first for any medical specialty society.
Self-declared financial conflicts of interest do not seem to affect results
Despite the perception that financial conflicts of interest influence the outcome of trials, a new study indicates that self-reported financial conflicts of interests are not associated with an increased likelihood of favourable results.
Can we mend a broken heart?
José M Pérez-Pomares, member of the European Society of Cardiology (ESC) Working Group on Development, Anatomy and Pathology, reviews the effects of ischemic heart disease and discusses the biological foundations of cell-based approaches to repair the damaged (infarcted) heart.
New course dedicated to resistant hypertension starts this week
The Resistant Hypertension Course, a joint initiative of the European Society of Hypertension (ESH), the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and PCR, will take place this week.
Intracoronary infusion of progenitor cells can be performed safely
Intracoronary administration of progenitor cells, in patients with acute myocardial infarction or patients with chronic heart failure, has an adequate safety profile
Promus Premier Everolimus-Eluting Platinum Chromium Stent System receives CE mark approval
According to a company release, the Promus Premier (Boston Scientific) is designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease.
The Combo dual stent will be featured at JIM
Information about OrbusNeich's Combo dual therapy stent will be presented during the Joint Interventional Meeting (JIM; 14–16 February, Rome, Italy)
Cardiorentis initiates first-ever acute heart failure Phase III clinical trial designed to assess early treatment on cardiovascular mortality and symptoms
Cardiorentis has initiated the first-ever acute heart failure (AHF) Phase III trial to be specifically designed to assess the effect of early treatment on cardiovascular mortality.
UK’S NICE issues draft guidance for acute management of STEMI
The UK's National Institute for Health and Clinical Excellence (NICE) has issued a draft version of its guideline for acute management of ST-segment-elevation myocardial infarction (STEMI) for public consultation
First US patient implanted with eSVS Mesh graft in new feasibility study
Kips Bay Medical has announced that the first patient in its US clinical feasibility trial has been implanted with the eSVS Mesh graft.
First implant of 25mm Portico TAVI valve performed in new study
St Jude Medical has announced that the first patient in its study evaluating the 25mm Portico transcatheter heart valve has been implanted with the device.
Therox launches new IDE study of its next generation super saturated oxygen therapy
Therox has announced it begun an investigational device exemption study of its next generation super saturated oxygen therapy for patients with acute myocardial infarction.
Svelte Medical Systems announces treatment of first patient in the DIRECT II drug-eluting stent study
The first patient in Svelte Medical Systems's DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study, the company announced, has been treated.
Natec Medical receives 510(k) clearance for the Tamarin Blue dilatation catheter
According to Natec Medical, the Tamarin Blue PTCA RX dilatation catheter features exceptional trackability and pushability, and a unique crossability into the tight stenosis with its tapered tip.
Post dilation is a safe and effective method of reducing paravalvular regurgitation
A new study indicates that post dilation, following balloon expandable TAVI, is a safe and effective way to reduce paravalvular regurgitation
Using dobutamine stress echocardiography to identify true-severe aortic stenosis
Philippe Pibarot reviews the use of stress imaging to determine the severity of aortic stenosis and its management. He spoke about this topic at PCR London Valves (30 September–2 October 2012, London, UK).
EnligHTN II renal denervation study enrols first patient
This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN Renal Denervation System (St Jude Medical) in patients with uncontrolled hypertension.
Direct Flow Medical receives CE mark for transcatheter aortic heart valve system
According to a press release, the Direct Flow Medical Transcatheter Aortic Valve System is designed to virtually eliminate aortic regurgitation by allowing complete assessment of haemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus.
Biosensors receives CE mark approval for BioFreedom
The CE mark approval for BioFreedom, a polymer-free drug-coated stent, was supported by strong data from the BioFreedom first-in-man study.
Updated “STICH” study finds benefit with surgical ventricular reconstruction in conjunction with CABG
Survival benefit found with surgical ventricular reconstruction plus coronary artery bypass graft procedure
Renal denervation procedure in Canada
A team at Peter Munk Cardiac Centre, University Health Network, Toronto, Canada, performs a renal de...
ReCor Medical receives the CE mark for its second generation ultrasound-based Paradise Renal Denervation System
According to a company release, the treatment parameters of this new device have been further enhanced to reduce energy delivery to 30 seconds by maximising cooling of the endothelium and efficiently treating the nerves circumferentially.
FDA gives approval to Bay Medical to enrol additional US patients in the eMESH I clinical study
The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during coronary artery bypass surgery.
MiCardia receives notification of a new German reimbursement code for the adjustment of its enCorSQ Mitral Valve Repair System
The company announced that this new code will provide additional reimbursement for the enCorSQ, a new approach to the long-term treatment of mitral valve disease.
OrbusNeich’s COMBO dual therapy stent to be featured during AsiaPCR/SingLIVE 2013 symposium
OrbusNeich is holding a symposium about its COMBO stent at AsiaPCR/SingLIVE 2013 (24–26 January, Singapore)
Longer CPR improves survival in both children and adults
Conventional thinking has been that CPR is futile after 20 minutes, but researchers in the USA have found that their study results challenge that assumption.
Do patients who have percutaneous coronary intervention need to stay overnight?
According to a study published in Catheterization and Cardiovascular Interventions, ambulatory percutaneous coronary intervention in patients with stable coronary artery disease is safe and effective
New risk score for left ventricular assist devices could be used for predicting mortality
The HeartMate II Risk Score, as outlined in the Journal of the American College of Cardiology, could be used to estimate mortality in patients receiving a HeartMate II left ventricular assist device
Covidien announces launch of therapeutic device for treatment of resistant hypertension
Placed percutaneously, a company press release explains, OneShot delivers radiofrequency energy in a circumferential manner to the renal arterial wall, and requires only a single treatment per artery.
CardioLogical Solutions receives an additional patent for its aortic embolic protection devices designed to prevent stroke and other ischaemic complications
CardioLogical Solutions has been given an additional patent for its aortic embolic protection devices
Phoenix Cardiac Devices announces start of clinical trial in India and Europe to test BACE device for treatment of mitral regurgitation without open heart surgery
Phoenix Cardiac Devices states a new study will assess the safety and efficacy of its BACE device for the treatment of mitral regurgitation with the goal of obtaining CE Mark approval
The evolution of percutaneous valve technology
Following on from the use of percutaneous technology in peripheral vascular disease and in coronary artery disease, percutaneous technology is now being used to treat valvular dysfunction. Jose L Navia and Sharif Al-Ruzzeh review its application in this context
CardioKinetix initiates landmark study of first-of-its-kind treatment for heart failure
A 39-year-old female with New York Heart Association (NYHA) class III heart failure has become the first patient to be implanted with the CardioKinetix's Parachute device in the company multicentre PARACHUTE IV trial
European Medicines Agency recommends suspension of laropiprant/nicotinic acid drugs
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended that the marketing, supply and authorisations for the laropiprant/nicotinic acid containing drugs Tredaptive, Pelzont and Trevaclyn be suspended
Abbott announces the FDA approval and US launch of its next-generation Xience Xpedition drug-eluting stent system
Abbott's next-generation Xience Xpedition drug-eluting stent system has received FDA approval and has been launched onto the US market
NeoChord receives CE mark for its DS1000 mitral valve repair device
As well as receiving the CE mark for its DS1000 mitral valve repair device, NeoChord has also started a 50-patient registry to assess the first European procedures with the device
St Jude Medical enrols first patient in ILUMIEN I study to develop guidance for stent optimisation
Study aims to improve clinical outcomes by offering physicians more information to further understand how FFR and OCT influence physician decision-making for coronary intervention
CardiacAssist receives FDA IDE approval for use of the TandemHeart system in pivotal clinical study
The TRIS (TandemHeart to Reduce Infarct Size) trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have suffered a severe heart attack.
Svelte Medical Systems announces treatment of first patient in the ACES effectiveness study
ACES is a randomised study designed to demonstrate the positive clinical benefit and impact on resource utilisation of the Svelte Acrobat Integrated Delivery System (IDS) compared with conventional stent devices.
One-year results from the Symplicity HTN-2 show sustained reduction in blood pressure with the Symplicity renal denervation system
Published data demonstrated that the Symplicity renal denervation system provides blood pressure reduction in patients with treatment-resistant hypertension sustained to 12 months.
Colibri Heart Valve, LLC announces successful clinical use of the first ready-to-use TAVI system
The world's first low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use, TAVI system reduces time from sterile package to valve deployment.
Predictors of cardiac death in patients with coronary chronic total occlusion not revascularised by PCI
Cosmo Godino, Cardio-Thoracic-Vascular Department, San Raffaele Hospital, Milan, Italy, writes that not all efforts should be directed toward technical and procedural aspects to achieve final chronic total occlusion-PCI recanalisation.
Celladon announces first European patient dosed in CUPID Phase 2b trial of MYDICAR for advanced heart failure
Celladon has announced that it has dosed the first European patient in its ongoing international Phase 2b clinical trial of MYDICAR.
First patient enrolled in LEADERS FREE study
Biosensors has announced the enrolment of the first patient in the LEADERS FREE study involving BioFreedom, the polymer-free drug-coated stent.
Biotronik announces first US implants of PRO-Kinetic Energy stent in BIOHELIX-I clinical trial
The BIOHELIX-I trial evaluates the safety and performance of the PRO-Kinetic Energy coronary, bare metal stent.
Readmission rates after axial flow left ventricular assist device implantation stabilise after six months
A study published ahead of print in the Journal of the American College of Cardiology indicates that the rates of readmission following axial flow left ventricular assist device (LVAD) implantation decrease during the first six months and thereafter stabilise.
Implantation of the Melody pulmonary valve associated with a high rate of success in patients with failed bioprosthetic valves
Matthew Gillespie, Philadelphia, USA, and others have found that transcatheter pulmonary valve implantation with the Melody valve (Medtronic) may be an effective treatment option for patients with failed bioprosthetic valves.
Sorin Group receives Japanese approval of Mitroflow Aortic Pericardial Heart Valve
Long-term studies (21 years) and 30 years of clinical use of the Mitroflow valve have demonstrated excellent haemodynamic performance, great durability and ease of use.
Revivent Myocardial Anchoring System for left ventricle restoration gets the CE mark
Revivent (BioVentrix) offers an alternative less-invasive option than surgical ventricular restoration to repair the left ventricle from damage done by a heart attack, enhancing performance of the heart's non-damaged myocardium.
First patient enrolled in the EVOLVE II study of the Synergy Coronary Stent System
EVOLVE II is designed to further assess the safety and effectiveness of the Synergy Stent System (Boston Scientific) and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.
CardiAQ Valve Technologies completes US$37.3 million series B round of financing
The funding will be used to further validate the company's transcatheter mitral valve implantation technology and is expected to carry the company through its feasibility and CE mark clinical trials.
Orbit II coronary trial completes patient enrolment
ORBIT II is evaluating the safety and effectiveness of Cardiovascular Systems' atherectomy technology in treating severely calcified coronary arteries.
Patients and physicians need to work together to get high blood pressure under control, new survey suggests
The new survey was undertaken by the American Medical Group Foundation, and released at the launch of the US healthcare campaign "Measure Up, Pressure Down".
Intercurrent events increase the risk of stroke and death after TAVI
Thomas Pilgrim, Bern, Switzerland, and others reported in Circulation: Cardiovascular Interventions that intercurrent events, such as access and bleeding complications, increase the cumulative risk of stroke and death after TAVI.
Paclitaxel drug-eluting balloons are associated with less angiographic late loss than paclitaxel drug-eluting stents in de novo small coronary vessels
Results from the BELLO study indicate that the use of a paclitaxel-eluting balloon for the treatment of de novo small vessel disease is associated with less angiographic late loss and similar rates of restenosis and revascularisation compared with a paclitaxel-eluting stent.
UK’s NICE guidance recommends treatment with ivabradine for some people with chronic heart failure
NICE has recommended ivabradine as an option for the treatment of people with chronic heart failure (NYHA class II to IV) with systolic dysfunction, who are in sinus rhythm and whose heart rate is 75 beats per minute or more and who have a left ventricular ejection fraction of 35% or less.
The National Cardiovascular Data Registry is a “national treasure”
For the first time, the National Cardiovascular Data Registry (NCDR) has published in the Journal of the American College of Cardiology a general report of data from the CathPCI registry, which characterises the clinical profile and outcomes of patients undergoing cardiac catheterisation and percutaneous coronary intervention procedures. Lead author of the report, Gregory Dehmer, reviews the report's key findings.
American College of Cardiology to launch new journal dedicated to heart failure
The Journal of the American College of Cardiology (JACC): Heart Failure will begin publishing in February 2013 on a bimonthly basis.
CardioDx to participate in PROMISE trial for assessment of stable patients with symptoms of coronary artery disease
The PROMISE study will test comparative effectiveness of anatomical versus functional non-invasive diagnostic tests for the assessment of stable symptomatic patients with possible coronary artery disease.
Tryton completes patient enrolment in pivotal study of a side branch stent
The Tryton pivotal study is an international randomised trial that compares a Tryton stent in the side branch vs. conventional provisional stenting in the side branch, with both arms of the trial utilising a standard drug-eluting stent in the main vessel.
First transapical implant of the Portico Transcatheter Aortic Heart Valve
The transapical procedure was performed by Anson Cheung, associate professor of surgery and director of cardiac transplant at St Paul's Hospital in Vancouver, Canada.
Siemens launches X-ray tube and detector technology for the Artis Q and Artis Q.zen angiography systems
According to a company release, in both the Artis Q and Artis Q.zen series, the new X-ray tube can help to identify small vessels up to 70% better than conventional X-ray tube technology.
Cardio3 BioSciences receives authorisation to begin world’s first phase III clinical trial in regenerative medicine for heart failure
Cardio3 BioSciences has announced it has received authorisation from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its CHART-1 (Congestive heart failure cardiopoietic regenerative therapy) European phase III trial for C3BS-CQR-1, an autologous stem cell therapy for heart failure, in Belgium.
Volcano Corporation to acquire Sync-Rx
Sync-Rx develops advanced software applications that optimise and facilitate transcatheter cardiovascular interventions using automated online image processing.
David Holmes
David Holmes, past president of the American College of Cardiology, principal investigator of the PROTECT AF trial and other several other studies in electrophysiology and interventional cardiology, spoke to Cardiovascular News about his career, mentors, research and interests outside medicine.
FDA approves HeartWare Ventricular Assist System as a bridge to heart transplantation
The approval was supported with data from the ADVANCE study, in which patients who received the HeatWare device achieved a 94% survival at six months. The trial also met its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study.
New data supports clinical utility and validity of Corus CAD blood-based gene expression test
Corus CAD (CardioDX) is a decision-making tool that can help physicians exclude obstructive coronary arterial disease as the cause of a stable non-diabetic patient's symptoms.
St Jude Medical gets the CE mark for its 23mm Portico Transcatheter Aortic Heart Valve
The valve that can be completely resheathed, repositioned or retrieved is designed for patients with severe aortic stenosis who are considered to be inoperable or high risk for conventional open-heart valve replacement surgery.
First US patient treated in SURTAVI trial for CoreValve system in intermediate-risk patients
The SURTAVI trial will evaluate whether the CoreValve system (Medtronic) is non-inferior to surgical aortic valve replacement, based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months.
Gore REDUCE principal investigators respond to recent RESPECT and PC clinical trial results of patent foramen closure treatment
"the Gore REDUCE clinical study shares notable similarities to the RESPECT study which we feel will help lead to a beneficial study outcome," said Gore REDUCE principal investigators.
Substudy from ADAPT-DES registry shows stent placement with intravascular ultrasound (IVUS) improves patient outcomes
Gregory W Stone, New York, USA, presented one-year results, at TCT, from a substudy of the largest study of its kind the ADAPT-DES registy showing that stent procedures guided by intravascular ultrasound (IVUS) resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.
Medtronic disagrees with US Court of Appeals ruling of CoreValve System
The Federal Circuit Court of Appeals has affirmed the April 2010 jury verdict from the Federal District Court of Delaware that the CoreValve System infringed a single Andersen patent held by Edwards Lifesciences.
Biotronik launches 3Flow Aspiration Catheter
This catheter is specifically designed to facilitate quick and accurate thrombus aspiration in myocardial infarction patients with ST-segment elevation.
Vagus nerve stimulation therapy for heart failure patients shows positive results at 24 months
Improvements in haemodynamics and quality of life were demonstrated at 24 months in an extended analysis of the pilot study which assessed vagus nerve stimulation therapy for heart failure patients with the CardioFit System (Biocontrol Medical).
FFR-guided PCI is “economically attractive”
Reporting on the results of an economic analysis of the FAME II study, at TCT, William Fearon, Stanford, USA, said that fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) was cost-effective, compared with medical management, in patients with stable coronary disease (CAD).
Boston Scientific enters renal denervation market with the acquisition of Vessix Vascular
Vessix Vascular is the developer of the Vessix Vascular V2 Renal Denervation System which has received CE mark in Europe and TGA approval in Australia.
Kips Bay Medical receives FDA approval to begin clinical study of the eSVS Mesh device in coronary artery bypass procedures
The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (SVG) support device during CABG procedures.
New PLATO sub-analysis demonstrates efficacy of ticagrelor compared to clopidogrel in acute coronary syndrome patients
Results showed that ticagrelor plus aspirin, compared to clopidogrel plus aspirin, reduced cardiovascular death, myocardial infraction and stroke in acute coronary syndrome patients regardless of coronary artery disease extent and treatment strategy.
New PLATO analysis evaluates the influence of high-sensitivity troponin biomarker status in NSTE-ACS patients managed with revascularisation or medical management
In the 86.3% of non–ST-elevation acute coronary syndrome (NSTE-ACS) patients with elevated hs-TnT, ticagrelor (Brillinta, Aztrazeneca) tablets reduced the composite of cardiovascular death, myocardial infarction, and stroke.
MASTER trial results for MGuard coronary stent published in the Journal of American College of Cardiology
The study met its primary endpoint showing the MGuard Embolic Protection Coronary Stent was significantly superior to the control arm of bare metal and drug-eluting stents in the treatment of heart attack patients.
Sorin Group launches Mitroflow Valsalva Conduit in the USA
The new heart device is used for simultaneous implantation of an aortic tissue valve and ascending aorta. It allows for safer device manipulation during assembly and implantation, thus limiting cardiac surgery time.
Timing of cell therapy following heart attack does not influence left ventricular functional recovery
Jay H Traverse, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, USA, and colleagues have found that timing of cardiovascular cell delivery within the first week after a heart attack does not have any effect improving left ventricular function following reperfusion.
Study evaluates mesenchymal stem cell therapies for cardiac patients
Joshua M Hare, Miami, USA, and colleagues have found that "transendocardial injection of allogeneic and autologous mesenchymal stem cells were both associated with low rates of treatment-emergent serious adverse events, including immunologic reactions in patients with left ventricular dysfunction due to ischaemic cardiomyopathy.
Medistim establishes UK subsidiary
The move strengthens Medistim's commitment to the UK market following NICE recommendation of its VeriQ flow measurement system for assessing graft blood flow during coronary artery bypass graft surgery.
Bypass surgery better than angioplasty in diabetic patients
A comparative study has shown, at five years, that diabetic patients who underwent bilateral internal thoracic artery grafting had a 13% greater survival rate, as well as a lower risk for non-fatal heart attacks, recurrent chest pain, and future re-interventions, compared to patients treated with percutaneous coronary intervention.
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System gets the CE mark
Synergy (Boston Scientific) features a PLGA polymer and everolimus drug coating that dissipates by three months.
Preliminary positive results from multicentre European trial of Engager transapical aortic valve presented at EACTS
First 30-day results of the Engager European pivotal trial support the safety and performance of the Engager transapical aortic valve system (Medtronic) in patients with severe aortic valve stenosis at high risk for surgical aortic valve replacement.
Coronary artery bypass grafting better than percutaneous coronary intervention, five-year comparative registry shows
A large comparative registry undertaken in a "real-world" setting has shown that, at five years, coronary artery bypass grafting demonstrated lower rates of death, myocardial infarction and target vessel revascularisation compared to percutaneous coronary intervention in patients with left main coronary artery or multivessel disease. Results were presented at EACTS.
Protégé NC non compliant drug-eluting balloon gets the CE mark
Non compliant percutaneous transluminal coronary angioplasty (PTCA) balloons are commonly used to post-dilatate stents and to treat in stent restenosis.
Vida Systems launches virtual echocardiography training system
The VidaEcho system features a simulated 3D anatomy of the heart, and the corresponding echo image; by moving a virtual echo probe handle with a mouse, users learn how the device will interact with the cardiac anatomy.
EXCELLA II three-year results show lower re-intervention rates with DESyne stent
Target lesion revascularisation rates at three years were significantly lower in favour of the DESyne stent as compared to the Endeavor zotarolimus-eluting stent (1.4% vs. 9.9%; p=0.008).
RESPECT trial for PFO closure provides clinical evidence of risk reduction in prevention of recurrent cryptogenic stroke, says St Jude
Data presented at TCT show that the primary analysis was not statistically significant but trended towards superiority with the Amplatzer device, while additional analyses demonstrated superiority.
Maquet receives FDA 510(k) clearance and CE mark approval for its new Sensation Plus 7.5F 40cc intra-aortic balloon catheter
This new fibre-optic device will allow clinicians to provide a higher-efficacy, faster intra-aortic balloon counterpulsation therapy to patients 5'0" to 5'4" tall.
Positive results for Pantera Lux drug-eluting balloon in both diabetic and non-diabetic patients presented at TCT
The Biotronik Pantera Lux Paclitaxel Releasing Balloon is a novel treatment for restenotic coronary artery lesions after drug-eluting or bare metal stenting.
Survey investigates barriers to wider TAVI adoption in Europe
A semi-structured survey suggests that more than 15% of patients suffering from severe symptomatic aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) did not receive the treatment for budget-related reasons in 2011.
Promus Element and Promus Element Plus receive CE mark approval for labeling update to include three-month dual anti-platelet therapy
This language outlines a minimum duration of three months of DAPT for certain patients who may need to interrupt or discontinue the medication for a variety of reasons and supports the strong safety profile for Promus Element and Promus Element Plus stents.
BioVentrix launches Revivent Myocardial Anchoring System at EACTS annual meeting
The Revivent system is intended for patients suffering from ischaemic cardiomyopathy.
For STEMI patients who receive stent, prior cardiac surgery does not mean worse outcomes
Contrary to previous data, STEMI patients with prior open heart surgery, or coronary artery bypass graft surgery (CABG) and receive a coronary stent have similar outcomes to patients without previous CABG, based on study of a large, prospective, regional STEMI network, presented at TCT.
MGuard Stent meets primary endpoint of MASTER trial, significantly improving prospects of heart attack survival
MGuard Embolic Protection Stent (InspireMD) shows a significant 29% improvement in complete ST resolution compared to bare metal or drug eluting stents.
Micro Interventional Devices initiates STASIS first-in-man clinical study of Permaseal
Permaseal is a transapical access device designed to enable self-sealing, sutureless cardiac access and closure of structural heart repair procedures including TAVI and mitral valve repair.
Parachute device gets CE mark for full range of sizes
The Parachute Ventricular Partitioning Device (CardioKinetix), available now in eight sizes, is a minimally invasive treatment used for percutaneous ventricular restoration therapy.
BioMatrix Flex improves clinical outcomes compared to Cypher Select for up to five years, LEADERS trial shows
BioMatrix Flex significantly reduced the risk of clinical events compared with Cypher Select, which was associated with a reduced risk of very late stent thrombosis.
Direct Flow Medical Transcatheter Aortic Valve System meets primary endpoint in DISCOVER trial
The primary endpoint, freedom from all-cause mortality from procedure to 30 days, was met at 97%. Freedom from all cause cardiovascular mortality at 30 days was 100%.
Bayer’s riociguat meets primary endpoint in phase III study in patients with pulmonary arterial hypertension
Riociguat demonstrates a statistically significant improvement in the six-minute walk test, a predictor of improved outcome in patients suffering from pulmonary arterial hypertension.
Kona Medical initiates WAVE I study of renal denervation therapy for hypertension
The Kona Surround Sound system utilises focused ultrasound, delivered from outside the body, to treat the nerves leading to and from the kidney.
Volcano announces global launch of PrimeWire Prestige Plus pressure guidewire
The PrimeWire Prestige Plus device will be used in six new Volcano-sponsored clinical studies to explore new indications in stable and unstable coronary artery disease, peripheral arterial disease and neurology.
New retrospective studies of prasugrel vs. clopidogrel presented at TCT
The studies evaluated hospital readmission rates for subsequent heart attack and initial hospitalisation costs in patients with acute coronary syndrome treated with a percutaneous coronary intervention and antiplatelet therapy, including prasugrel or clopidogrel.
Stentys receives FDA approval to initiate first US trial with Self-Apposing stent
Under this FDA-approved IDE, up to 880 ST-elevation myocardial infarction (STEMI) patients at 50 sites in the USA and worldwide will be enrolled in the APPOSITION V clinical trial.
Early interruption of dual antiplatelet therapy caused no increased risk of blood clots to one year, RESOLUTE clinical trial shows
"This analysis adds provocative new insight to ongoing discussions about the minimal duration of dual antiplatelet therapy required to safeguard patients with the latest generation drug-eluting stents," said Sigmund Silber, presenter of the RESOLUTE data at TCT.
ISAR-LEFT MAIN 2: Second generation drug-eluting stents safe and effective for left main coronary artery lesions
The ISAR-LEFT MAIN 2 trial is the first and largest performed randomised, multicentre comparison trial between zotarolimus-eluting and everolimus-eluting stents in unprotected left main coronary artery lesions.
PARTNER B confirms benefits of TAVI in inoperable patients over three years
After three years of follow-up, the benefits of TAVI were sustained as measured by all-cause mortality, cardiovascular mortality, repeat hospitalisation, and functional status, according to new data presented at TCT.
Integrative approach and management of acute cardiovascular diseases theme of first annual meeting of ACCA
Acute cardiac care experts who met at Acute Cardiac Care Congress 2012 in Istanbul, Turkey, said that patients with severe chest pain should call the emergency number immediately as pre-hospital care is essential to survival.
Cost-effectiveness study determines FFR can improve health while reducing economic burden in the UK
An analysis of the benefits to using a fractional flow reserve-guided intervention strategy found that the technology can improve patient outcomes while saving significant amounts of money.
Two-year follow-up of Symplicity HTN-1 data confirms significant and sustained blood pressure reduction in expanded cohort of patients
New data presented at the TCT congress show sustained blood pressure reduction and safety with Symplicity Renal Denervation system in patients with treatment-resistant hypertension.
Svelte announces FDA approval to initiate a pivotal study of its coronary stent Integrated Delivery System
Approved by the FDA under an investigational device exemption, the study will evaluate the safety and effectiveness of the device in approximately 370 patients at up to 30 sites in the USA.
Zotarolimus-eluting stent successfully treats long lesions and small vessels in multiple studies
The Resolute drug-eluting stent from Medtronic delivered successful clinical results two challenging characteristics of coronary artery lesions commonly found in patients with diabetes.
ADVANCE study results show high survival rates and improved quality of life for patients using the CoreValve system
Medtronic has announced new findings from the Medtronic CoreValve ADVANCE study for one year survival and health-related quality of life.
FDA approves Gore Septal Occluder for use in Gore REDUCE clinical study
Gore is introducing the technology in the REDUCE study for prevention of recurrent stroke in patent foramen ovale patients.
PLATINUM long lesion clinical results show no heart attack or stent thrombosis at two-year follow-up
The Platinum Long Lesion study met its primary endpoint of target lesion failure at 12 months with a 3.2% rate for the Promus Element Stent (Boston Scientific) in the per protocol population compared to a pre-specified performance goal of 19.4% based on historical outcomes for the Taxus Express Stent.
FDA expands use of Sapien artificial heart valve
The expanded indication includes patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
Cappella Medical announces positive long term follow-up results for its Sideguard Technology at TCT 2012
Data suggest Sidegaurd stent has long term benefits in treating bifurcation disease
First patient enrolled in Gore Septal Occluder clinical study for atrial septal defect
The US prospective, multicentre, single-arm, clinical study will evaluate the safety and efficacy of the new Gore Septal Occluder in the treatment of percutaneous, trancatheter closure of ostium secundum atrial septal defect.
Could virtual simulation improve trainees’ skills in cardiac catheterisation?
Akshay Bagai, Toronto, Canada, and colleagues have found that mentored simulation may help less proficient cardiac catheterisation operators to improve their skills.
Functional bicuspid aortic valves associated with improved outcomes compared with other morphology types
A patient with a functional bicuspid valve is less likely to require repeat valvuloplasty, aortic valve replacement, death, or a heart transplant than a patient with other types of valve morphology, according to a study published by Shiraz Maskatia, Texas Children's Hospital, Houston, USA, and colleagues in Catheterization and Cardiovascular Interventions.
Psychological factors before and after renal denervation for resistant hypertension
Denise Fischer, Homburg, Germany, says that renal denervation may have a positive effect in psychological processes, stress perception and processing as well as in quality of life.
CathPCI registry shows contemporary state of interventional cardiology practice in USA
The report published online in The Journal of the American College of Cardiology (JACC) analyses data from 1.1 million patients who underwent diagnostic cardiac catheterisation procedures and 941,248 patients treated with percutaneous coronary intervention from January 2010 to June 2011.
FDA clears True Dilatation Balloon Valvuloplasty Catheter
The device, which is also CE-marked, features a balloon specifically designed to prevent balloon ruptures in transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) procedures.
SCAI survey shows heart patients’ quality of life significantly improved after angioplasty
In the survey, conducted by the Society for Cardiovascular Angiography and Interventions (SCAI), four out of five patients say their lives have changed for the better following angioplasty.
SV Life Sciences and Third Rock Ventures launch medical device company Cibiem
Cibiem will develop a proprietary, minimally invasive, catheter-based approach focused on carotid body modulation for the treatment of sympathetic nervous system-mediated diseases.
FAME II trial results published in New England Journal of Medicine
Data from the FAME II trial has shown that patients with fractional flow reserve (FFR)-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone.
Infraredx and Philips join to develop a new standard of cath lab integration for true vessel characterisation
The collaboration is focused on integrating Infraredx's true vessel characterisation (TVC) Imaging System with Philips' Allura Xper catheterisation (cath) lab imaging systems
One-year interim results from APPOSITION III study of Self-Apposing stent to be presented at TCT
APPOSITION III is a prospective, single-arm, multicentre, post-market trial to assess the long term performance of the Stentys Self-Apposing stent in routine clinical practice in 1,000 STEMI patients.
Synergy micro-pump for heart failure patients to be featured at TCT
CircuLite has announced that its Synergy Circulatory Support System will be included in four presentations at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (Miami, USA, 22–26 October).
Siemens delivers advanced cardiovascular CT training with the British Institute of Radiology
The four day training course offered hands-on training, analysis of cardiac CT data sets including post-percutaneous coronary intervention and surgery assessment skills.
Risk of premature cardiovascular death may be increased by extreme temperatures
The study in Brisbane, Australia, is the first in which researchers examined the association between daily average temperature and "years of life lost" due to cardiovascular disease.
Research associates sudden cardiac death and a thin placenta at birth
The new study, published in the International Journal of Epidemiology, also found that sudden death was associated independently with poor educational attainment.
Biosensors extends licensing agreement with Terumo to sell BioMatrix technology globally
Under the agreement, Terumo will continue to incorporate BioMatrix in the production, marketing and selling of its drug"eluting stents in markets worldwide, outside of the United States.
Argentina heart attack death rate nearly halved over 15 years
Results from the Argentine Registry of Acute Coronary Syndromes (SCAR) were presented by Ricardo Villarreal at the 38th Argentine Congress of Cardiology in Buenos Aires.
NayaMed launches new e-procurement platform
The system gives healthcare professionals 24-hour access to digital inventory management, communities, eLearning, product information and technical support in order to reduce costs.
EnCorSQ Mitral Valve Repair System presented at the Mitral Days Heart Surgery Symposium
A scientific presentation and a live procedure of adjustment of the MiCardia device were presented by Martin Andreas and Markus Czesla to 200 cardiac surgeons and other professionals in Stuttgart, Germany.
BioVentrix initiates phase II study of system for heart failure treatment in Western Europe
The study with the Revivent Myocardial Anchoring System for use in Less Invasive Ventricular Enhancement procedures commenced in Europe under the guidance of Louis Labrousse, Bordeaux-Pessac, France.
First patient enrolled in REPRISE II trial to evaluate the safety and performance of the Lotus Valve System
The results of the clinical trial with the Boston Scientific repositionable and retrievable device are expected to be used to support CE mark and other international regulatory approvals.
Cardionovum announces distribution network in 57 countries for its drug-eluting balloons and stents
The company has been commercialising its CE-marked paclitaxel-coated drug-coated balloon for coronary (Primus) and peripheral (Legflow) applications since March 2012.
Edwards Lifesciences completes acquisition of BMEYE
The company specialises in the development of non-invasive technology for advanced haemodynamic monitoring, which can be used in the surgical, intensive care, emergency room and cardiology settings.
Svelte announces appointment of Jack Darby as president and chief executive officer
Darby, who has 20 years of experience in the medical device industry, with most of those in the interventional cardiovascular space, was the business unit head of Bayer Interventional before joining Svelte.
Trevena completes phase 2a study of TRV027 in patients with advanced heart failure
TRV027 has shown improvement in haemodynamics and has been well-tolerated in patients with stable advanced heart failure, supporting advancement into a phase 2b study in acute decompensated heart failure patients.
St Jude Medical launches MediGuide Technology
The MediGuide Technology reduces the need for fluoroscopic images during cardiovascular procedures.
UK’s NICE consults on new hypertension draft quality standard
The draft quality standard on hypertension describes measurable markers of high-quality, cost-effective care to drive improvements in the effectiveness, safety and experience of care for people with hypertension.
Blood pressure levels are unreliable predictors of mortality and cardiovascular events in very elderly patients
Athanase Benetos, Nancy, France, and colleagues have found that higher blood pressure levels in very old patients do not predict mortality or major cardiovascular events but low pulse pressure amplification in this population does predict such events.
Can haemodynamic parameters help to predict which patients will have poor outcomes after TAVI?
According to a study published in the European Journal of Heart Failure, severe aortic stenosis patients with low-mean gradient and reduced left ventricular ejection fraction (LVEF) have worse outcomes after transcatheter aortic valve implantation (TAVI) than patients with preserved LVEF and high-mean gradient.
ESC 2015 Congress to be held in London
The announcement was made at a press conference in London by Boris Johnson, Mayor of London; Kevin Murphy, CEO of ExCeL London and Kim Fox, representing the ESC.
Medtronic completes first-in-man study for investigational next-generation multi-electrode renal denervation system
According to the company, the next-generation system will feature a new four electrode catheter that delivers radiofrequency energy simultaneously and is designed to significantly reduce ablation time during renal denervation procedures.
New data reinforce positive clinical outcomes for direct aortic implants with the CoreValve system
New data presented at the PCR London Valves 2012 meeting has shown a 97% procedural success implantation with the CoreValve System (Medtronic) through a direct aortic approach.
The economics of TAVI
A team of researchers at the Erasmus University Medical Center, Rotterdam, The Netherlands, performed a cost-analysis of 84 propensity matched surgical and transcatheter aortic valve implantation patients. Ruben Osnabrugge, one of the authors of the study, writes for Cardiovascular News key conclusions of the analysis and compares it with the economic outcomes reported from the PARTNER trial.
Resverlogix completes enrolment in ASSURE trial for patients with coronary arterial disease
ASSURE will evaluate the ability of RVX-208, Resverlogix's BET protein inhibitor, to regress atherosclerotic disease versus placebo using intravascular ultrasound (IVUS) technology in patients with coronary arterial disease.
Cardiac Dimensions initiates European distribution of Carillon Mitral Contour System
The CE-marked Carillon Mitral Contour System is designed to reduce functional mitral regurgitation while reducing mitral annulus dilatation upon device deployment.
First clinical trial for Symplicity Renal Denervation System starts in Japan
The clinical trial is an open-label study that will randomise subjects 1:1 to renal denervation vs. no denervation with both groups receiving maximal tolerated doses of antihypertensive medications.
FDA clears Emerge Balloon Dilatation Catheter
The Emerge Catheter (Boston Scientific) is a next-generation pre-dilatation balloon catheter designed to treat challenging lesions in coronary arteries.
CoreValve Evolut 23mm transcatheter aortic valve gets the CE mark
According to Medtronic, the new valve incorporates technology that optimises fit, thereby promoting sealing between the prosthetic valve and the native valve.
Stentys launches enhanced stent-delivery system for Self-Apposing Stent
The new catheter to implant the Stentys Self-Apposing Stent adds a hydrophilic (slippery) coating and an ergonomic handle that considerably facilitates stent implantation in tortuous vessels.
Renal denervation may be cost-effective for resistant hypertension
A study published in the Journal of the American College of Cardiology, based on data from the Symplicity HTN-2 trial, suggests that renal denervation may be a cost-effective method of managing resistant hypertension and may result in a reduction in cardiovascular morbidity and mortality in the long term.
“New generation TAVI devices will push complication rates down”
Alain Cribier implanted the first transcatheter aortic valve in a patient at the University Hospital of Rouen, France, on 16 April 2002, he told Cardiovascular News how transcatheter aortic valve implantation (TAVI) began, how he dealt with criticism in the early days, complications with the procedure and the changes to the concept of the heart team.
Absorb Bioresorbable Vascular Scaffold launched in Europe, parts of Asia Pacific and Latin America
The international launch of Absorb, a first-of-its-kind device for the treatment of coronary arterial disease, is supported by five clinical studies in more than 20 countries around the world.
Women have a higher peri-procedural risk during percutaneous coronary intervention than men but similar long-term outcomes
A large cohort study by Monique Anderson, Durham, USA, and colleagues have found that women experienced higher rates of all-cause in-hospital mortality and were more likely to experience a peri-procedural myocardial infarction, bleeding, and vascular complications than men undergoing percutaneous coronary intervention.
Tiara valve for mitral regurgitation shows positive results in acute preclinical data
A study reported in JACC has shown successful implantation of the Tiara valve (Neovasc) in 81% of the test animals, with no obstruction of the left ventricular outflow tract, no pericardial effusion, no encroachment on the aortic valve, no transvalvular gradients and most importantly, no significant paravalvular leak.
Coronary artery stenting combined with minimally invasive valve surgery may be an alternative to CABG and valve surgery
A study lead by researchers from the Mount Sinai Medical Center in Miami, USA, has found that patients with coronary valvular disease who were treated with a hybrid approach combining coronary artery stenting with minimally invasive valve surgery showed significantly better outcomes than patients who had standard sternotomy coronary bypass and valve surgery.
Affinity Fusion oxygenation system for adult cardiac surgery gets the CE mark
Affinity Fusion (Medtronic) is designed to serve as a patient's lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures.
FDA clears CVInsight medical device to monitor cardiovascular health
CVInsight (Intelomed) displays vital information such as functional oxygen saturation of arterial haemoglobin (Sp02) and pulse rate of adult and paediatric patients.
Boston Scientific to acquire BridgePoint Medical
BridgePoint Medical is the developer of an FDA cleared and CE marked catheter-based system designed to treat coronary chronic total occlusions.
Primus Drug-Coated Balloon shows efficacy in patients with in-stent restenosis of drug-eluting stents
A preclinical study and a first-in-man clinical study of the Primus Drug-Coated Balloon (Cardionovum) have shown "high procedural efficacy," and "no adverse clinical events observed out to six months."
Perceval S bioprosthetic valve gets the CE mark approval for extended indications
The Perceval S valve (Sorin Group) is now approved for use in patients 65 years of age or older with aortic valve stenosis or steno-insufficiency.
Multicentre trial confirms efficacy of combined CT angiography and myocardial perfusion imaging using 320-detector row CT
Results of the CORE320 trial were presented during an ESC Hotline Session by João A C Lima, professor of Medicine and Radiology at the Johns Hopkins University School of Medicine.
Abiomed receives FDA 510(k) clearance for Impella Percutaneous Heart Pump
The company plans to have a controlled launch with top heart hospitals in the United States, with full US commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.
Bernard Chevalier
Bernard Chevalier, interventional cardiologist, Cardiovascular Institute Paris-Sud, Jacques Cartier Hospital, Massy, France, talked to Cardiovascular News about his career, current research and innovations in interventional cardiology. He also spoke about a special interest in bioresorbable stent trials and his hobbies, including collecting fine wine.
New study shows how changes in cardiac protein lead to heart failure
The study conducted by scientists from the Johns Hopkins Children's Center, Baltimore, USA, and published online ahead of print in Circulation, can pave the way to new diagnostic tools and therapies for heart failure.
Terumo launches the VirtuoSaph Plus Endoscopic Vessel Harvesting System
The VirtuoSaph Plus system provides an endoscopic approach to vessel harvesting, and is used for coronary artery and peripheral artery bypass graft procedures.
SCAI launches app to support appropriate use criteria in coronary revascularisation procedures
The Society for Cardiovascular Angiography and Interventions (SCAI) has launched the new SCAI Quality Improvement Toolkit (SCAI-QIT) Appropriate Use Criteria (AUC) and Guidelines app designed to provide information on coronary revascularisation appropriate use criteria.
Synergy Circulatory Support System receives the CE mark
Synergy is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.
Janssen submits complete response to FDA on rivaroxaban
The response includes information on reduction of risk of secondary cardiovascular events in patients with acute coronary syndrome.
Largest trial comparing drug-eluting stents does not find a difference between Endeavor and Cypher for stent thrombosis
The PROTECT study, which was presented at the ESC congress in Munich, failed to fulfil its hypothesis that the Endeavor zotarolimus-eluting stent would be superior to the Cypher sirolimus-eluting stent in terms of reducing the rate of definite or probable stent thrombosis.
Combined CT coronary angiography and myocardial perfusion imaging using 320-detector row CT help to identify flow-limiting lessions requiring revascularisation, CORE320 study shows
The CORE320 study is a worldwide multicentre trial assessing the diagnostic performance of combined CTA and CTP as compared to traditional assessment of flow-limiting stenosis by means of SPECT-MPI and invasive coronary angiography.
Renal stenting lowers blood pressure in patients with severe hypertension, HERCULES trial shows
The HERCULES trial found that patients with higher blood pressure levels at baseline had the most dramatic reduction in blood pressure following renal artery stenting with the RX Herculink Elite Stent (Abbott Vascular).
Desyne BD Novolimus Eluting Coronary Stent System receives CE mark
The Elixir Desyne BD Novolimus Eluting Coronary Stent System was evaluated in the EXCELLA BD randomised clinical trial as compared to the control Endeavor Zotarolimus Eluting Coronary Stent System (Medtronic).
The future of renal denervation rests on selecting the right patient
"We need to be very careful not to kill a promising technology with incorrect patient selection," Pierre-François Plouin, Paris, France, warned delegates at the EuroPCR Great Debate 2012 on renal denervation. In the debate, Plouin and four other experts in interventional cardiology, interventional radiology and nephrology agreed that identifying the right group of patients is key for the future of the technique.
EnligHTN safe and effective for the treatment of resistant hypertension
Results from the EnligHTN I trial showed that a reduction of 28 mmHg points systolic blood pressure seen after one month, remained stable at three months, using the EnligHTN renal denervation system.
TAVI restricted to very old or very sick patients
Cardiologists are restricting the use of transcatheter aortic valve implantation (TAVI) to very old or very sick patients at high surgical risk, according to results of the Transcatheter Valve Treatment (TCVT) Sentinel Pilot registry presented at the ESC Congress.
Medtronic completes high risk patient enrolment in CoreValve US pivotal trial and gains FDA approval to study intermediate risk patients in SURTAVI trial
More than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery have been included in the CoreValve US pivotal trial.
Sunshine Heart submits IDE to FDA for C-Pulse Heart Assist System pivotal trial
If approved, the investigational device exemption (IDE) pivotal trial will study the C-Pulse System in patients suffering with moderate to severe heart failure.
Initial results from GARY registry released at ESC
First results from the German Aortic Valve Registry (GARY) show that participating centres using transcatheter aortic valve implantation (TAVI) are adhering to current guidelines for patient selection.
Heart separation device improves three year outcomes in heart failure patients
A novel non-invasive device which separates healthy and damaged heart muscle and restores ventricle function improves three-year outcomes in patients with ischaemic heart failure.
PROTECT study confirms long-term safety of drug-eluting coronary stents
Largest prospective randomised drug-eluting stent trial ever presented, ESC late-breaker on the PROTECT study reveals low rates of stent thrombosis through three years of follow-up.
New ESC guidelines recommend ticagrelor in acute coronary syndromes patients with ST-elevation
Ticagrelor received a class I recommendation from the ESC in the revised Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with STEMI.
NEJM publishes FAME II trial results revealing better patient outcomes with FFR-guided cardiac stenting
Instances of hospital re-admission leading to urgent revascularisation were reduced by 86% for patients in the FFR-guided percutaneous coronary intervention arm of the trial.
Cardiovascular effects of Japan’s 2011 earthquake and tsunami: Incidence rises with the seismic peak
Following an investigation of the ambulance records in the area close to the epicentre of the earthquake investigators found that the occurrence of cardiovascular conditions increased sharply after the earthquake.
FFRCT improves ability to identify flow-restricting arterial blockages over the use of CT alone
Results from the DeFACTO study assessing the performance of non-invasive fractional flow reserve (FFRCT) technology were presented at ESC and published simultaneously in JAMA
Medtronic launches Resolute Integrity Coronary Stent System in Japan
The device's regulatory and reimbursement approvals earlier this year were supported by the results of RESOLUTE Japan, a single-arm study that enrolled 100 patients at 14 Japanese centres.
Randomised trial data show Symplicity Renal Denervation System continues to demonstrate significant blood pressure reduction in all treatment groups
An eighteen-month update from the SYMPLICITY HTN-2 randomised clinical trial was presented at ESC Congress 2012 on 26 August 2012 in Munich, Germany.
Philips and Corindus announce distribution agreement to sell Corindus’ robotic-assisted interventional cardiology system in the USA
Philips becomes the exclusive distributor of Corindus' CorPath 200 System, the world's first robotic-assisted system for the minimally invasive treatment of obstructed coronary arteries.
“The new EACVI will promote and represent all aspects of cardiovascular imaging in Europe”
The European Society of Cardiology board has approved a change in the name of the European Association of Echocardiography (EAE) to European Association of Cardiovascular Imaging (EACVI). Luigi Badano, EAE president, spoke to Cardiovascular News about this change.
Blue Medical announces appointment of new CEO
The appointment of Noël Coopmans followed the introduction of Blue Medical's new drug-eluting technologies in March of this year and the development of additional coronary and peripheral applications.
Toshiba’s Aquilion RXL receives FDA clearance
According to Toshiba, its new 16-detector row CT system provides faster imaging reconstruction and helps lower radiation dose for safer patient exams.
Inappropriate restrictions on life saving technology in the UK
Stephen Westaby and David Taggart, Department of Cardiothoracic Surgery, John Radcliffe Hospital, Oxford, UK, published an editorial in Heart criticising the fact that UK's National Health Service does not fund circulatory support equipment to treat cardiogenic shock in the majority of cardiac tertiary centres.
Xience Xpedition drug-eluting stent gets CE mark
The approval includes expanded CE mark indications to treat patients with complex coronary arterial disease and a minimum duration of three months of dual anti-platelet therapy.
First patient treated in phase II STOP-HF trial of stem cell therapy for cardiovascular disease
The 90-patient, placebo-controlled, randomised double-blinded phase II study is evaluating the safety and efficacy for JVS-100 in patients with late stage heart failure.
MASTER trial shows positive results for the MGuard embolic protection stent
The multicentre randomised trial of MGuard (InspireMD) demonstrated a positive outcome in treating patients suffering acute myocardial infarction when compared to commercially-approved bare metal or drug-eluting stents.
First cardiac surgery with FMwand Surgical System completed in USA
FMwand's precise control of thermal energy minimises damage to tissue surrounding the incision, preserving healthier, viable tissue.
Vascular Solutions acquires Venture catheter from St Jude Medical
Venture is a deflectable-tip catheter used to provide guidewire directional control in challenging coronary and peripheral interventional procedures.
FDA approves RELIVE trial to assess the Jarvik 2000 device for destination therapy
The Jarvik 2000 is used to provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant.
Retia Medical raises US$7 million to develop cardiovascular monitor
Retia's cardiovascular monitor is a less-invasive system to monitor cardiac output and other key measures of the cardiovascular system accurately when patients go into shock.
Link discovered between Bisphenol-A and severe coronary artery stenosis
Researchers from the Peninsula College of Medicine and Dentistry (PCMD), University of Exeter, and University of Cambridge have for the first time established a link between high levels of urinary Bisphenol-A (BPA) and severe coronary artery stenosis.
FDA approves first generic Actos to treat type 2 diabetes
The manufacturer, Mylan Pharmaceuticals, gained FDA approval for 15mg, 30mg and 45mg pioglitazone tablets.
NICE opens consultation on new device for measuring blood pressure and detecting atrial fibrillation
On 15 August, the UK's National Institute for Health and Clinical Excellence (NICE) opened a consultation on its draft medical technology guidance on the use of WatchBP Home A (Microlife), a device that measures blood pressure and detects atrial fibrillation.
Can we reduce paravalvular regurgitation after TAVI?
"A strategy incorporating measurable anatomical and procedural variables together with post-implantation corrective measures can reduce the incidence of paravalvular aortic regurgitation after transfemoral TAVI," says Mohamed Abdel-Wahab, consultant cardiologist, Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
Catheter-based ultrasound technology lower resistant hypertension, SOUND ITV study shows
Three-month results from the SOUND-ITV study have shown that the catheter-based ultrasound system from Sound Interventions significantly lower blood pressure in patients whose blood pressure was unable to be controlled by conventional pharmaceutical therapy.
Excor Pediatric Ventricular Assist Device shows greater survival rates than standard-of-care bridging therapy, study shows
A study published in the current issue of the New England Journal of Medicine (NEJM) has shown that survival using the Excor Pediatric Ventricular Assist Device (VAD) (Berlin Heart) is significantly greater than the standard-of-care (extracorporeal membrane oxygenation, or ECMO) as a bridging therapy for children in need of a heart transplant.
Cardionovum to launch Prolimus Biograde drug-eluting coronary stent system
The new Prolimus Biograde DES technology promotes early re-endothelialisation and rapid healing.
FDA grants post approval study of Excor paediatric ventricular assist device
The purpose of the post approval study for the Excor paediatric VAD (Berlin Heart) is to evaluate whether safety and outcomes of the device in the commercial setting are comparable to the safety and outcomes shown in the IDE study.
First-in-human case of Arterial Remodeling Technologies’ biodegradable stent reported
The case is part of the ARTDIVA (Arterial remodeling transient dismantling vascular angioplasty) clinical trial.
FDA clears robotic-assisted system for percutaneous coronary intervention
Corindus Vascular Robotics has received FDA 510(k) clearance for its CorPath 200 System to be used in percutaneous coronary intervention (PCI) procedures. Results of the PRECISE trial showed that PCI with the system was successfully completed without having to convert to manual percutaneous coronary intervention in 98.8% of patients and without device-related complications.
Pacemaker dependency after transcatheter aortic valve implantation
Robert M A van der Boon, Erasmus Medical Center, Rotterdam, The Netherlands, writes that the possibility that conduction abnormalities may resolve early or late after TAVI puts the clinical implications of permanent pacemaker implantation after TAVI in a different perspective.
Radiation exposure during coronary angiography via transradial or transfemoral approaches: Does operator experience matter?
Binita Shah, New York University School of Medicine, New York, USA, explains the results of a study that demonstrated that even in the hands of experienced operators, radiation exposure is higher when using transradial approach compared with transfemoral approach.
Medtronic begins global clinical trial evaluating CoreValve system implantation in intermediate-risk patients
The trial, called SURTAVI (Medtronic CoreValve surgical replacement and transcatheter aortic valve implantation) trial, will evaluate the potential for the minimally-invasive CoreValve system to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement today.
FDA clears expanded matrix of Glider PTCA balloon catheter
Glider (TriReme) is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 – 3.5mm and in lengths from 4mm to 20mm.
Preliminary results of CT angiography method for assessing haemodynamic significance of coronary lesions released
Rcadia Medical Imaging announced results of an initial study intended to demonstrate the feasibility of a proprietary technique that uses coronary CT angiography studies (cCTA) as a non-invasive alternative to assess the haemodynamic significance of coronary lesions.
Janssen withdraws supplemental new drug application for rivaroxaban
Janssen R&D has announced it is withdrawing the supplemental new drug application (sNDA) to the FDA for the use of rivaroxaban (Xarelto, Bayer/Janssen) to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).
First patients treated with Cardiovascular Systems atherectomy device for calcified coronary arteries
The treatments are part of the company's ORBIT II trial, which is now over 70% enrolled.
Edwards Intuity valve system cleared for US trial
The TRANSFORM trial is the first US clinical trial of a rapid deployment system for surgical aortic valve replacement procedures.
Somatom Definition Edge Single-Source CT cleared in USA
The Somatom Definition Edge CT system offers high image quality, dose reduction and dual energy in clinical settings, including the emergency department.
CVRx launches European Registry to monitor hypertension patients treated with Barostim neo device
On 2 July, CVRx launched a European post-market hypertension registry to track performance outcomes and physician experience using the company's Barostim neo device for hypertension. The registry is expected to enrol up to 500 patients.
Edwards receives the CE mark for Ascendra+ system for transapical and transaortic delivery of Sapien XT valve
The CE mark includes a transaortic indication for delivery of the valve through mini-sternotomy or mini-thoracotomy, after which the valve is then implanted through a small incision in the aorta.
John Ormiston
John Ormiston, Auckland, New Zealand, has investigated important innovations in interventional cardiology such as bioresorbable stents, TAVI and renal denervation. He spoke to Cardiovascular News on these technologies.
First study to evaluate alternative to warfarin for mechanical heart valve patients launched
RE-ALIGN is designed to evaluate dabigatran etexilate (Pradaxa, Boehringer Ingelheim) as an alternative to warfarin for use in patients with mechanical heart valves requiring anticoagulation therapy.
Ticagrelor cost-effective versus generic clopidogrel
The cost-effectiveness of ticagrelor (AstraZeneca) was driven by the mortality benefit seen in the pivotal PLATO trial, which showed ticagrelor was cost-effective across all major patient subgroups.
CardiAQ announces first-in-human nonsurgical percutaneous implantation of its bioprosthetic mitral heart valve
The Transcatheter Mitral Valve Implantation (TMVI) procedure was performed on 12 June 2012, at The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
APPOSITION IV clinical study starts patients’ enrolment
The randomised study will enrol 150 heart attack patients who will be treated with either the Stentys stent or Medtronic's Resolute drug-eluting stent.
Robotic-assisted percutaneous coronary intervention is safe and reduces exposure to radiation
Results of PRECISE, a multicentre, pivotal investigation with the CorPath 200 robotic system, were presented at a late-breaking clinical trial at the SCAI annual meeting in Las Vegas.
First-in-man use of an embolic protection device for patients undergoing TAVI reported
The first-in-man experience with the Claret Pro cerebral protection system showed that more than half of the patients had debris captured during transcatheter valve implantation.
FDA panel backs use of Sapien valve for high-risk surgical patients
The FDA Circulatory System Devices Panel voted unanimously, with one abstention, that TAVI with the Edwards Sapien device should be approved for use in patient considered high-risk for surgery.
Edwards receives IDE for trial of heart valve tissue treatment platform
Edwards Lifesciences announced that it has received conditional Investigational Device Exemption (IDE) approval from the FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve.
New European guidelines set to benefit heart failure patients in the UK
The ESC has announced an update to their guidelines for the management of chronic heart failure highlighting the crucial role of mineralocorticoid receptor antagonists (MRA).
Sanofi and Regeneron publish positive phase 2 results for lipid-lowering PCSK9 antibody
Across four different dosing regimens tested, patients receiving SAR236553/REGN727 for 12 weeks achieved a mean LDL-cholesterol reduction from baseline of 28.9% to 67.9%, compared to 10.7% in patients receiving placebo.
Resolute stent shows positive outcomes in diabetic and non-diabetic heart disease patients
At two years of follow-up in the RESOLUTE clinical study, rates of target lesion failure are 7.1% for patients without diabetes and 9.6% for patients with diabetes.
HeartWare Ventricular Assist System shows positive performance in end-stage heart failure patients
Results of ADVANCE a US clinical trial evaluating the use of the HeartWare Ventricular Assist System (HeartWare International) as a bridge to heart transplantation in patients with advanced heart failure were published on 22 May ahead of print in Circulation.
New renal denervation systems unveiled at EuroPCR
Two new denervation systems were launched at EuroPCR (Paris, 15–18 May 2012). Covidien unveiled its OneShot system and St Jude Medical announced the launch of the EnligHTN system.
FDA advisory committee votes against approval of rivaroxaban for acute coronary syndrome
The FDA's Cardiovascular and Renal Drugs advisory committee voted six to four against rivaroxaban's new indication based on missing data on early patient withdrawals from the phase 3 ATLAS ACS 2 TIMI 51 study.
Pantera Lux Paclitaxel Releasing Balloon shows positive outcomes in diabetic and non-diabetic subgroups
Six-month results from the DELUX registry demonstrated positive safety and efficacy outcomes for the Pantera Lux Paclitaxel Releasing Balloon (Biotronik) in more than 1000 patients.
Promus Element stent demonstrates long-term safety and effectiveness in PLATINUM Small Vessel study
Two-year clinical data shows low adverse event rates, including no myocardial infarction or stent thrombosis.
Parachute Ventricular Partitioning device for heart failure shows positive outcomes at two years
Results from 31 treated US and European patients demonstrate a near-full New York Heart Association (NYHA) class improvement at two years compared to baseline, also a reduction in left ventricular volume was maintained.
Survival benefits similar in women and men in TAVI procedures with the CoreValve system
Data from the CoreValve ADVANCE study found that survival rates were nearly identical between genders, with no statistical differences in 30-day and 6-month all-cause mortality, cardiovascular mortality or the 30-day MACCE endpoint.
Low major adverse events observed 3 years after treatment with MGuard in acute myocardial infarction patients
Lead investigator, Dariusz Dudek, Jagiellonian University, Krakow, Poland, presented positive three-year results from the extended follow-up MAGICAL trial at a InspireMD-sponsored symposium at EuroPCR.
Stentys launches new thrombectomy device
The Stentys AC thrombectomy device is designed to safely recover debris and can be used in concert with its Self-Apposing devices, Stentys BMS and Stentys DES.
Results from BELLO and PACIFIER trials presented at EuroPCR
Data shows statistically significant advantages of using an IN.PACT drug-eluting balloon (Medtronic) over a corresponding conventional treatment for coronary and peripheral artery disease, respectively.
Edwards Sapien XT transcatheter valve shows positive patient outcomes in 94 centres post-approval study
Thirty-day outcomes for patients enrolled in the SOURCE XT Registry demonstrated low all-cause mortality of 6.3% and low rates of procedural complications.
Combo Dual Therapy Stent shows favourable clinical and safety outcomes at 12-month follow-up
Michael Haude told EuroPCR delegates that in-stent and in-segment late loss and binary restenosis rates were low for Combo and comparable to those of Taxus; Combo also showed a uniform, homogeneous neointimal response.
Resolute Integrity drug-eluting stent gets CE mark approval for new indications in Europe
The Resolute Integrity DES (Medtronic) is now indicated in countries approving the CE mark for the following patient and lesiontypes: acute coronary syndromes, acute myocardial infarction, unstable angina; diabetes mellitus; bifurcations; multi-vessel disease; total occlusions and chronic total occlusions; and in-stent restenosis. All but the indications for diabetes and multi-vessel disease are new.
REPRISE I trial shows positive outcomes for the Lotus Transcatheter Aortic Valve System
The Lotus Aortic Valve System (Boston Scientific) showed successful deployment in all patients (11) with virtually no paravalvular regurgitation after valve placement or at discharge.
Twelve-month ENERGY registry results presented at EuroPCR
ENERGY is a registry in a broad patient population investigating the safety and clinical performance of the PRO-Kinetic Energy bare metal stent system (Boston Scientific) in 1,016 patients.
EVOLVE trial confirms comparable safety and effectiveness data of the Synergy stent versus Promus Element stent
The Synergy stent (Boston Scientific) shows low rates of revascularisation and no cardiac-related deaths or stent thrombosis at one year.
Preclinical data for Neovasc’s Tiara transcatheter mitral valve programme to be presented at EuroPCR 2012
Neovasc has announced that its Tiara technology under development for the transcatheter treatment of mitral valve disease will be featured in three scientific sessions at EuroPCR 2012 (Paris, France, 15–18 May).
Xience Prime and Xience V drug-eluting stents receive CE mark indication for minimum three-month duration of dual anti-platelet therapy
Three-month dual anti-platelet therapy is the shortest duration for any major drug-eluting stent in Europe.
St Jude Medical launches EnligHTN Renal Denervation System at EuroPCR
Clinical data from the EnligHTN I trial about the safety and efficacy of the company's renal denervation technology will be presented on Wednesday 16 May.
Cardionovum to launch two drug-eluting balloon dilatation catheter product families at EuroPCR 2012
Cardionovum has announced that it will launch two drug-eluting balloon (DEB) dilatation catheter product families at EuroPCR 2012 congress: Paclitaxel-coated drug-eluting balloons for coronary (Primus) and peripheral (Legflow) applications.
Boston Scientific and Philips Healthcare announce collaboration in imaging business
Boston Scientific and Philips Healthcare have announced a collaboration enabling Philips to sell Boston Scientific Imaging equipment in connection with its Allura Xper catheterisation (cath) lab systems throughout the world.
Maquet Cardiovascular receives FDA 510(k) clearance for new Mega Intra-Aortic Balloon Catheter sizes
The FDA has cleared the Mega 7.5Fr 30cc and 40cc intra-aortic balloon catheters. These larger volumes provide patients with greater haemodynamic support, regardless of their height.
Janssen Research & Development submits supplemental new drug application to FDA for rivaroxaban
The new drug application seeks approval to reduce the risk of stent thrombosis in patients with acute coronary syndrome.
PRECISE study shows robotically enhanced PCI is safe and feasible
Results of the multicentre PRECISE study show effectiveness of a robotic-assisted system for patients and enhanced safety for interventional cardiologists performing percutaneous coronary interventions.
True Dilatation Balloon Valvuloplasty Catheter receives CE mark
The True Dilatation Balloon Valvuloplasty Catheter (Loma Vista) is specifically designed to prevent balloon ruptures in balloon aortic valvuloplasty and transcatheter aortic valve implantation procedures.
Hitachi Aloka Medical works with Cardiff University to validate vascular imaging tools
Hitachi Aloka Medical announced its collaboration with Alan Fraser of the Cardiff University School of Medicine to establish industry standards for the development and evaluation of diagnostic tools that examine how the heart interacts with larger arteries.
Cardiovascular Research Foundation announces initiation of HORIZONS-AMI II clinical trial
The trial will evaluate Promus Element platinum-chromium everolimus-eluting stents versus Omega bare-metal stents in patients with heart attack undergoing primary angioplasty with bivalirudin anticoagulation.
New guidelines deliver concise messages for implementing cardiovascular prevention
The new European Society of Cardiology (ESC) guidelines, launched at EuroPrevent 2012, stress that cardiovascular disease prevention should be a life-long effort that starts in the womb and lasts to the end of life.
Statin use associated with a 50% mortality reduction after percutaneous coronary intervention
The results of the study, published in the April 2012 edition of Eurointervention, also showed that patients using atorvastatin had a 23% lower mortality than those using simvastatin.
C-Cath Injection Catheter gets CE mark
Cardio3 BioSciences has announced that it has received CE mark for its intra-myocardial C-Cath Injection Catheter.
Sound Interventions completes first-in-human trial of ultrasound-based renal denervation system for resistant hypertension
Patients enrolled in the SOUND-ITV study will be followed for 12 months to evaluate the procedure's effectiveness in lowering blood pressure.
TRITON trial shows positive outcomes with the Edwards Intuity valve system
New data from the TRITON trial show that the Edwards Intuity valve system facilitates small-incision surgery for aortic valve replacement, with a high procedural success rate, and consistent and sustained haemodynamic valve performance at one year.
Edwards launches ThruPort IntraClude intra-aortic occlusion device
ThruPort IntraClude is indicated for use in patients undergoing cardiopulmonary bypass, including during mitral heart valve repair or replacement surgery using a minimally invasive approach.
Long-term outcome similar with thrombus aspiration and stents in STEMI
Post-PASSION trial analysis published in the Catheterization and Cardiovascular Interventions journal confirms no difference in terms of major adverse cardiac events.
New femoral artery access site closure device shows efficacy, safety and ease of use in a wide range of patients
Recent data from commercial use of the device in 41 patients at St Marien Hospital, Siegen, Germany, showed 100% success rate and no complications.
Medicare to cover transcatheter aortic valve implantation procedure
Edwards Lifesciences announced that, effective immediately, the CMS will reimburse TAVI procedures for US patients with symptomatic aortic stenosis under specified criteria.
Toshiba’s Aquilion Prime 80 CT system receives FDA clearance
Producing high-quality clinical images and reducing radiation exposure with Adaptive Iterative Dose Reduction 3D (AIDR 3D), the system can generate 80 unique slices per rotation.
Vivid E9 Cardiac Ultrasound System with 4D transesophageal echocardiography probe receives FDA clearance
According to GE Healhcare, the system provides innovative tools designed to help improve workflow efficiency through simplified image acquisition, intuitive navigation and advanced yet easy to use quantification.
Vessix receives the CE mark for V2 Renal Denervation System for treatment of hypertension
The V2 System is an over-the-wire balloon catheter with an array of electrodes mounted in a precise pattern designed to deliver a modest dose of radiofrequency energy to disrupt the renal nerves.
Rogue DNA’ plays key role in heart failure, study shows
DNA from the heart's own cells plays a role in heart failure by mistakenly activating the body's immune system, research co-funded by the British Heart Foundation has found.
Symplicity HTN-2 trial shows significant blood pressure reduction, with no evidence of renal impairment, at six months post treatment
Data presented on 27 April at the 22nd annual scientific meeting of the European Society of Hypertension showed patients (n=84) who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001) at six months following treatment compared with baseline.
Promus stent approved in Canada
The Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Boston Scientific) has received Health Canada approval for the treatment of patients with coronary artery disease.
Emerge PTCA Dilatation Catheter gets CE mark approval
The Emerge catheter (Boston Scientific) includes a 1.2mm diameter balloon option that features an ultra-low 0.017" tip profile and low crossing profiles designed to cross tight coronary lesions.
Ischaemic tolerant stem cells produce significant improvement in cardiac function after heart attack
At three months, patients who received cell therapy experienced an 11 point improvement in the ejection fraction in comparison with the control group.
Enrolment in clinical trial to evaluate Lotus Aortic Valve System completed
The results of the prospective, single-arm feasibility REPRISE I trial, which enrolled 11 patients at three sites in Australia, will be presented at EuroPCR in Paris.
Biodegradable stent safe for long-term treatment of coronary artery disease
In the study, researchers followed 50 Japanese patients who received 84 Igaki-Tamai stents to treat 63 lesions between September 1998 and April 2000.
St Jude launches new Trifecta heart valve in Japan
The valve is constructed using a polyester and tissue-covered, fatigue resistant, high strength titanium stent to ensure structural integrity of the valve.
Abiomed receives CE mark for Impella Catheter-Deployed Ventricular Assist Device
The Impella cVAD1 is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is inserted percutaneously, without the need for surgical intervention.
Total Artificial Heart receives FDA’s humanitarian use device designation
SynCardia Systems announced that the FDA has approved a humanitarian use device designation for its temporary Total Artificial Heart to be used for destination therapy in addition to its current premarket approval as a bridge to transplant.
Xience Prime drug-eluting stent receives approval in Japan
Approval of Xience Prime in Japan was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated Xience Prime in approximately 500 patients with coronary artery disease.
UK’s NICE updates guidance on TAVI
The main updates are recommendations on the use of transcatheter aortic valve implantation (TAVI) for people who would be considered unsuitable for open heart surgery.
REMEDEE study results for Genous stent presented at ACC
Data from REMEDEE demonstrate the safety and feasibility of the Genous stent (OrbusNeich) for patients with ST-segment elevation myocardial infarction (STEMI) and showed no incidence of very late stent thrombosis.
Is magnetic resonance imaging a useful tool to identify the cause of malignant ventricular arrhythmias?
James White, London, Canada, writes about the first evaluation of diagnostic utility for cardiac imaging in patients presenting with ventricular arrhythmias.
Positive outcomes from Cohort A of PARTNER trial presented at ACC
Two-year follow-up of patients in the PARTNER trial supports the use of transcatheter aortic valve implantation (TAVI) as an alternative to surgery in selected high-risk patients with aortic stenosis.
Cobalt-chromium everolimus-eluting stents show lowest thrombosis rates at two years
A meta-analysis published online in The Lancet and presented at the American College of Cardiology's (ACC) 61st Annual Scientific Session in Chicago, USA, shows that cobalt-chromium (Co-Cr) everolimus-eluting stents (Xience, Abbott Vascular) have much lower short-term and long-term stent thrombosis rates than both bare metal stents and all other drug-eluting stents.
CardioKinetix claims positive results in study using percutaneous ventricular restoration
German sub-study from the PARACHUTE Cohort B trial continued to show positive results after heart failure patients were treated with the Parachute device.
CLOSURE I trial published in The New England Journal of Medicine
The randomised trial has concluded that a catheter procedure to close a patent foramen ovale is no more effective than medical therapy in preventing recurrent strokes.
Depression increases death risk in coronary stent patients
After seven years of follow-up, depressed patients were 1.5 times more likely to have died than non-depressed patients, research presented at 12th Annual Spring Meeting on Cardiovascular Nursing has shown.
VectraCor receives FDA approval for real-time detection of ECG changes suggestive of acute myorcardial infarction
The VectraplexECG System uses only five electrodes to detect ECG changes suggestive of acute myorcardial infarction and derive a 15-lead ECG.
St Jude Medical announces next-generation PressureWire for FFR measurement
The PressureWire with Agile Tip was designed to replicate the performance of standard percutaneous coronary intervention guidewires and deliver exceptional handling even in the most challenging anatomies.
Resolute drug-eluting stent delivers durable clinical outcomes through two years in major studies
Recently FDA-approved, device shows consistently low event rates across broad spectrum of coronary artery disease patients, including those with diabetes.
Symplicity renal denervation system demonstrates significant and sustained blood pressure reduction out to three years
Data from two clinical trials presented at the 61st Annual Scientific Session of the American College of Cardiology show consistent effectiveness and safety up to three years.
Data presented at ACC reinforce positive clinical outcomes for patients receiving Medtronic’s CoreValve System
Results of the ADVANCE study showed that survival rates were high at both 30 days (95.5%) and six months (87.2%) in patients with severe aortic stenosis who are at high-risk for surgery.
Elective use of an intra-aortic balloon pump during high-risk angioplasty associated with a 34% reduction in mortality
Results from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1) were presented at the American College of Cardiology's 61st Annual Scientific Session.
Analysis of the PLATINUM Workhorse trial demonstrates superior efficacy of Promus Element Platinum Chromium stent compared to Promus
A statistically significant reduction in recurrent ischaemia requiring repeat revascularisation was present between the first and second year of follow-up with the platinum chromium stent.
BioCardia and Juventas to start phase II trial for heart failure treatment
The phase II trial of JVS-100 will evaluate the safety and efficacy of Stromal-cell Derived Factor 1 (SDF-1)─a strong chemo-attractant of stem cells and progenitor cells that promote tissue preservation and increased and sustained healing of wounded tissue in heart failure patients.
RenalGuard system approved in Israel
"RenalGuard (PLC) offers us a potential method to reduce the incidence of contrast-induced nephropathy, a major issue when performing interventional procedures requiring contrast agents with high-risk patients," said Eugenia Nikolsky, Rambam Medical Center, Haifa, Israel.
Are there gender-related factors influencing the outcome of TAVI patients?
Marie-Claude Morice, Massy, France, analyses the results of a single-centre study comparing the outcomes of transcatheter aortic valve implantation in men and women.
Myocardial perfusion improves diagnostic accuracy of CT angiography in acute chest pain patients
The addition of computed tomography (CT) perfusion to CT angiography improves diagnostic accuracy of CT angiography in acute chest pain patients, a study presented at the European Congress of Radiology 2012 in Vienna, Austria, shows.
Fluoroscopy times and radiation exposure during renal denervation compared to coronary procedures
A retrospective analysis conducted in Germany shows that fluoroscopy times and radiation exposure in patients undergoing renal denervation are similar to those in patients undergoing routine diagnostic catheterisation with elective percutaneous coronary intervention but lower than in patients undergoing emergency intervention.
“We will see steady progress in percutaneous mitral valve therapy over the next couple of years”
Catheter-based mitral valve repair with MitraClip (Abbott Vascular) is the best-studied type of percutaneous mitral valve therapy, said Ted Feldman, Evanston, USA, at the International Symposium on Endovascular Therapy (ISET) in Miami.
Nuloy coronary stent system gets CE mark
The Nuloy coronary stent (ICON Interventional Systems) has extremely thin struts, superior flexibility, improved deliverability and lower profile.
Genous stent is a safe and effective option in STEMI patients
Data from the recently published GENIA study show that the Genous stent (OrbusNeich) is associated with low rates of stent thrombosis and target lesion revascularisation.
Miracor receives Austrian funding to begin RAMSES clinical trial of its Picso system for acute coronary syndrome patients
The RAMSES trial is designed to understand how Picso can help acute coronary syndrome patients with large anterior infarcts having ECG changes with poor microcirculation after revascularisation.
Boston Scientific launches Promus Element stent system in Japan
The Promus Element stent system incorporates a platinum chromium (PtCr) alloy with an innovative stent design and an advanced catheter delivery system designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease.
New clinical trial will explore adult autologous cells as treatment for chronic myocardial ischaemia
The trial, sponsored by Baxter, will enrol approximately 450 patients across 50 clinical sites in the United States, who will be randomised to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care.
Drug-eluting balloon found safe and effective for de novo lesions in Valentines Trial II
The treatment with the Dior device resulted in low major adverse cardiac events, target lesion revascularisation and target vessel revascularisation rates according to Antonio Serra, Barcelona, Spain.
Bayer’s rivaroxaban granted Priority Review by US FDA to prevent secondary cardiovascular events in patients with acute coronary syndrome
This decision was based upon data from the global Phase III ATLAS ACS 2-TIMI 51 study, which showed that rivaroxaban significantly reduced the composite of cardiovascular death, myocardial infarction and stroke, versus placebo.
Percutaneous coronary intervention in patients with severe aortic stenosis: Implications for TAVI
Sachin Goel and Samir Kapadia, Cleveland Clinic, USA, say that PCI can be performed in severe aortic stenosis patients and coronary artery disease without an increase in short-term mortality or procedural complications.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
The US Food and Drug Administration has announced safety changes to the labeling for some widely used statins.
First patients treated in clinical study using the Vessix V2 Renal Denervation System
REDUCE-HTN is a non-randomised, prospective, 64-patient clinical study designed to validate the clinical performance of the Vessix system for medication-resistant hypertensive patients.
American College of Chest Physicians includes ticagrelor in Antithrombotic Therapy and Prevention of Thrombosis guidelines
The new oral antiplatelet drug is now included in seven sets of cardiovascular treatment guidelines across the world, two sets in the EU, four in the USA and one in Canada.
DSM, UMC Utrecht to study feasibility of transcatheter heart valves using Dyneema Purity fibres
DSM will contribute its technology to enable UMC Utrecht to develop and evaluate a prototype of a non-biological supportive scaffold for the minimally invasive treatment of valvular and vascular diseases.
Sorin announces first implant in US study of stentless pericardial aortic valve
The first patient was enrolled in the Freedom Solo IDE study at St Vincent's Heart Center of Indiana in Indianapolis by David Heimansohn, the study's principal investigator.
Injectable gel could repair tissue damaged by heart attack
The hydrogel is made from cardiac tissue that is stripped of heart muscle cells through, freeze-dried and milled into powder form, and then liquefied into a fluid that can be injected into the heart.
Boston Scientific receives industry’s first FDA approval for drug-eluting coronary stent use in heart attack patients
Ion and Taxus Liberte paclitaxel-eluting stent systems are now approved for treating patients with acute myocardial infarction in the USA.
Paradise ultrasound transcatheter renal denervation system is CE marked
Paradise (ReCor Medical) denervates all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.
Edwards Intuity Valve System receives CE mark
The system, which consists of a bovine pericardial heart valve and novel delivery system, facilitates small incision surgery and rapid valve deployment during aortic valve replacement procedures.
Resolute Integrity drug-eluting stent obtains FDA approval for treating coronary artery disease
The approval stems from the results of a series of studies involving the Medtronic device, which showed powerful results across a broad spectrum of patients, including those with diabetes.
St Jude Medical initiates a study to evaluate the economic impact of FFR in Asia and Australia
Country-specific analysis will evaluate the cost effectiveness of an FFR-guided intervention strategy for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia.
Sexual activity is safe for most heart patients, American Heart Association statement suggests
The American Heart Association has published a statement, online in Circulation: Journal of the American Heart Association, containing recommendations on sexual activity for patients with stable cardiovascular disease.
New FFR trial to stop enrolment following positive interim analysis
Follow-up trial to landmark FAME trial examines benefits of using FFR-guided assessment for stent procedures with optimal medical treatment compared to optimal medical treatment alone.
Primary PCI as a national reperfusion “strategy” for STEMI
Christian J Terkelsen, Department of Cardiology, Aarhus University Hospital, Skejby, Denmark, writes about the country's reperfusion strategy and the importance of prehospital diagnosis and field-triage.
Jeffrey Moses
Jeffrey Moses, New York, USA, notes that percutaneous aortic valve implantation is probably the most transformative technology in the last 20 years and describes his father's experience of undergoing a TAVI procedure, in this interview with Cardiovascular News. He also spoke about his career, influences, areas of research and his love for skiing and playing tennis.
Transapical aortic valve replacement improves with experience
Experience and improved patient selection have improved outcomes with transapical aortic valve implantation in the PARTNER trial Non-Randomized Continued Access (NRCA) programme, new results have shown.
An inside view into the FAST trial
Manuel Castella, Barcelona, Spain, was a principal investigator in the FAST trial, he gives his insights into the design and outcomes of this trial that set out to compare endocardial catheter ablation isolation of the pulmonary veins vs. minimally invasive thoracoscopic surgical epicardial isolation for atrial fibrillation treatment.
First patient enrolled in clinical trial assessing guideline-based heart failure management in primary care setting
The IMPROVE HF bridge study will examine specific gaps in implementation of guideline-recommended treatment in heart failure patients post-hospital discharge.
Boston Scientific launches Promus Element Plus PtCr stent system in Europe
The Promus Element Plus stent system employs an advanced low-profile delivery system featuring a dual-layer balloon designed to enable precise stent delivery across challenging lesions and reduce balloon growth during inflation to facilitate high-pressure stent deployment in treating patients with coronary artery disease.
CardioKinetix receives expanded CE mark approval for percutaneous left ventricular partitioning device for treatment of ischaemic heart failure
The Parachute is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischaemic heart failure following a heart attack.
APPOSITION III clinical trial closes enrolment ahead of time
APPOSITION III is a multicentre, prospective, observational registry that seeks to evaluate the long term safety and performance of the Stentys Self-Apposing coronary stent to treat acute myocardial infarction.
TAVI through direct aortic approach shows positive outcomes
Data presented at the Society of Thoracic Surgeons (STS) 48th Annual Meeting (Fort Lauderdale, USA, 28 January–1 February) demonstrate positive outcomes when the CoreValve system (Medtronic) is implanted using the direct aortic approach.
GE Healthcare cardiac CT scanner receives NICE’s positive recommendation
The UK's National Institute for Health and Clinical Excellence (NICE) has recommended the Discovery CT750 HD scanner as an option for first line cardiac imaging of the coronary arteries in people with suspected coronary artery disease and for 'difficult to image' patients.
Medtronic enters exclusive distribution agreement with Miami Instruments
Medtronic will initially distribute Miami Instruments' Joseph Lamelas knot pusher and the Joseph Lamelas atrial lift system used during minimally invasive cardiac surgery procedures.
Freedom portable driver for Total Artificial Heart finalist for the 2012 MEDTEC Europe Innovation Awards
The Freedom portable driver (Syncardia Systems) allows stable Syncardia's Total Artificial Heart patients to be discharged from the hospital while they wait for a matching donor heart.
First patient enrolled in PreSERVE phase 2 trial for acute myocardial infarction
The study is a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells.
Placenta could help repair mothers’ injured heart
Stem cells from the placenta can travel to injured tissues in a mother's heart during pregnancy and create new cardiac cells, according to a late-breaking basic science abstract presented at the American Heart Association's Scientific Sessions 2011.
New data from the SOURCE registry
Olaf Wendler, London, UK, summarises and comments on one-year outcomes from the SOURCE registry. SOURCE provided procedural results with the commercialised Edwards Sapien valve.
Drug-eluting balloons are a promising tool in treatment of in-stent restenosis
Percutaneous coronary intervention with a drug-eluting balloon for in-stent restenosis is a promising effective therapeutic option with an unexpected low repeat restenosis and target lesion revascularisation rate, according to research presented at the American Heart Association's Scientific Sessions 2011.
St George’s Valve Technology course now part of the CX Symposium
For the first time, the St George's Valve Technology Symposium now in its seventh year will be an integral part of the Charing Cross International Symposium. Now called the CX St George's Valve Technology Symposium, the event will take place during the first two days of the 34th CX Symposium (14–17 April 2012, Imperial College London, UK).
Novel drug shows promise as a “bridge” therapy for patients undergoing cardiac surgery
A study published in the Journal of the American Medical Association (JAMA) shows that the novel drug cangrelor (The Medicines Company) is associated with a higher rate of platelet inhibition, compared with placebo, in patients who have discontinued thienopyridine therapy prior to cardiac surgery.
New antiplatelet helps bridge stent patients to cardiac surgery
Results from the BRIDGE trial showed 99% of cangrelor-treated patients maintained target levels of platelet inhibition for all time points measured over the bridging period to cardiac surgery compared to 19% of placebo patients with no significant excess in surgical bleeding complications.
CHILL-MI trial starts patient enrolment to study endovascular cooling treatment of STEMI patients
The study will further evaluate the safety and effectiveness of the InnerCool RTx endovascular cooling system (Phillips) to reduce reperfusion injury in acute ST-elevation myocardial infarction (STEMI) patients.
Polymers technology demonstrates effective non-viral DNA delivery for in vivo cardiac study
Techulon's polymers were used as delivery agents for an NF-κB oligodeoxynucleotide (ODN) decoy used to limit myocardial infarction during an ischaemic-repurfusion event simulating a heart attack.
Genous stent achieves good, comparable clinical outcomes in patients discontinuing dual antiplatelet therapy at 30 days and at six months
Results were taken from a 12-month follow-up post-hoc analysis of e-HEALING, a multicentre, worldwide prospective clinical registry conducted in 31 countries outside of the United States that included 4,939 patients.
CircuLite awarded grant to develop right-heart circulatory support system for patients with pulmonary arterial hypertension
The Cardiovascular Medical Research and Education Fund (CMREF) has awarded CircuLite approximately US$950,000 to support ongoing work to modify the design of its existing Synergy system so that it can be used to provide circulatory support for a failing right heart.
PRESERVATION I clinical trial to study Bioabsorbable Cardiac Matrix
The Bioabsorbable Cardiac Matrix (Ikaria) an aqueous mixture of sodium alginate and calcium gluconate is being investigated to prevent ventricular remodeling and subsequent congestive heart failure following acute myocardial infarction.
Janssen submits FDA application for rivaroxaban to reduce secondary cardiovascular events in patients with acute coronary syndrome
The filing is supported by data from the pivotal phase III ATLAS ACS 2 TIMI 51trial presented in November at the American Heart Association Scientific Sessions.
FDA approves Excor Pediatric Ventricular Assist Device (VAD)
The system is intended to bridge paediatric patients from newborns to teenagers awaiting heart transplantation from days up to several months, until a donor heart becomes available.
First patient treated with Portico transcatheter aortic heart valve in Europe
This first implant is part of St Jude's European clinical trial to assess the safety and effectiveness of the Portico heart valve for patients with severe symptomatic aortic stenosis, who are at high risk for conventional open-heart valve replacement therapy.
Balloon aortic valvuloplasty in the current era
Amar Krishnaswamy and Murat Tuzcu, Cleveland Clinic, USA, speak on the resurgence of balloon aortic valvuloplasty as a treatment to bridge severely symptomatic patients to transcatheter or surgical aortic valve replacement, or to better understand the contribution of aortic stenosis to functional limitation in patients with multiple comorbidities.
“MRI is more accurate than SPECT in detecting the presence of significant coronary artery disease”
Sven Plein, Leeds, UK spoke to Cardiovascular News about the current trends in cardiovascular magnetic resonance (CMR), the benefits of this modality and the recent use of CMR as an endpoint in acute myocardial infarction trials.
Genous stent safe and effective treatment option for acute coronary syndrome with stent thrombosis after fracture of a drug-eluting stent, case study shows
This is the case study of a patient with non-ST elevation myocardial infarction (NSTEMI), which shows successful clinical outcomes at 12-month follow-up post Genous stent implantation after only one month of dual antiplatelet therapy (DAPT).
Abbott initiates ABSORB II clinical trial
Approximately 500 patients with coronary artery disease will be enrolled at about 40 investigational sites in Europe and New Zealand to evaluate the Absorb BSV compared to a metallic drug-eluting stent.
Largest clinical trial of point-of-care DNA testing begins in Italy
The GENE-MATRIX study will determine optimal antiplatelet therapy with the Spartan RX CYP2C19 point-of-care DNA testing system which will be used to test heart attack patients receiving cardiac stents.
BioMatrix Flex improves long-term clinical outcomes, LEADERS trial shows
Four-year results from the LEADERS trial show that BioMatrix Flex, Biosensors' Biolimus A9-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis compared to that of a drug-eluting stent system with a durable polymer coating.
Genous stent safe with very short-term dual antiplatelet therapy
Data from a multicentre trial show that the Genous stent (OrbusNeich) is safe when accompanied by only 10 days of dual antiplatelet therapy.
First patients enrolled in European post-market study of eSVS Mesh
The eSVS Mesh (Kips Bay Medical) is a nitinol mesh sleeve that, when placed over a saphenous vein graft during CABG surgery, is designed to improve the structural characteristics and long-term performance of the vein graft.
FDA approves Promus Element stent system
The Promus Element stent (Boston Scientific) uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables thinner struts and enhanced visibility.
Vasodilator-free measure of stenosis severity is comparable to FFR, ADVISE study shows
A novel technology to measure stenosis severity yields similar results to traditional fractional flow reserve (FFR) without the use of adenosine to induce maximum hyperemia.
Benefits with TAVI increase at two years in inoperable patients
The PARTNER Trial Cohort B results demonstrate widening survival benefit for transcatheter aortic valve implantation (TAVI) patients at two years, with mortality for TAVI at 43.4% compared to 67.6% for medical therapy. These new results were presented by Raj Makkar, USA, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, San Francisco, USA.
Ulrich Sigwart
Ulrich Sigwart, Switzerland, is one of the pioneers in coronary angioplasty, having performed his first case in 1978. He told Cardiovascular News about this first experience, his most memorable cases, and why he considers himself a "nomad".
Long-term data reinforce performance of the Absorb Bioresorbable Vascular Scaffold
At five years, there were no reports of cardiac deaths, blood clots or ischaemia-driven target lesion revascularisation in the first stage of the ABSORB trial.
Portico transcatheter aortic heart valve shows promising results in feasibility study
At 30 days, study results from the Portico transcatheter aortic heart valve (St Jude Medical) showed no device or procedure-related adverse events or death.
Synergy stent safe and effective compared to Promus Element stent, EVOLVE trial shows
"The Synergy stent (Boston Scientific) met the primary non-inferiority endpoint of six-month late loss compared to the Promus Element stent (Boston Scientific), demonstrating effectiveness of drug elution from this abluminal bioabsorbable polymer," said Ian T Meredith, principal investigator of the trial.
REMEDEE study meets primary endpoint: OrbusNeich’s Combo dual therapy stent is non-inferior to DES
The Combo stent, the worlds' first dual therapy stent (DTS), combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with Genous, OrbusNeich's proven endothelial progenitor cell (EPC) capture technology, to accelerate re-endothelialisation.
Pantera Lux paclitaxel releasing balloon for restonic coronary artery lesions after drug-eluting or bare metal stenting shows positive results
Six-month data from the DELUX registry and 12-month outcomes from the PEPPER study, both demonstrated favourable safety and efficacy results for the Pantera Lux paclitaxel releasing balloon (Biotronik).
Genous stent demonstrates long-term safety and efficacy in large patient population
OrbusNeich announced that three-year clinical outcomes data from the use of the Genous stent for percutaneous coronary interventions in a large, real-world patient population demonstrate the device's long-term safety and efficacy.
PLATINUM Long Lesion trial shows favourable outcomes for Promus Element stent system
The PLATINUM Long Lesion study met its primary endpoint of target lesion failure at 12 months with a 3.2% rate for the Promus Element (Boston Scientific) stent in the per protocol population compared to a pre-specified performance goal of 19.4%.
Positive preliminary data from DESSOLVE I study presented at TCT
John Ormiston, Auckland, New Zealand, presented latest data from the first-in-human DESSOLVE I trial of the MiStent Sirolimus drug-eluting coronary stent system (Micell Technologies) at the Transcatheter Cardiovascular Therapeutics Conference (TCT) 2011, in San Francisco, USA.
PERSEUS trial demonstrates positive outcomes for the ION stent for coronary artery disease
"The excellent clinical results at two years confirm the ION (Boston Scientific) stent's safety and efficacy in workhorse lesions and suggest superior performance relative to bare-metal stents in small vessels," said Louis Cannon, USA, principal investigator of the trial.
Genous stent demonstrates most rapid coronary vessel healing compared to bare metal and drug-eluting stents at 14 days post-implantation
The Genous stent (OrbusNeich) had 69.7% healed and 5.3% malapposed struts compared to 56.7% healed and 19.7% malapposed struts for the Blazer stent (OrbusNeich), 55.2% healed and 13.9% malapposed struts for the SolarFlex stent (Disa Vascular) and 34% healed and 45.7% malapposed struts for the Nobori stent (Terumo).
Medtronic CoreValve system gets CE mark for new direct aortic approach to TAVI
According to Medtronic, early evaluations have shown the direct aortic approach demonstrates high procedural success rates and high overall survival rates that are similar to those from transfemoral and subclavian approaches.
Abbott to present new data for key vascular products at TCT 2011
Latest data on the MitraClip system for mitral valve repair, the Absorb bioresorbable vascular scaffold for the treatment of coronay artery disease, Xience Prime everolimus eluting coronary stent system and Xience V will be presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (7 – 11 November, San Francisco, USA).
First patient enrolled in the Gore REDUCE clinical trial in the UK
The Gore REDUCE clinical study is designed to demonstrate the safety and effectiveness of Gore Helex Septal Occluder for patent foramen ovale closure in patients with a history of cryptogenic stroke.
Medtronic begins transcatheter aortic valve trial in Japan
The trial will evaluate the safety and effectiveness of Medtronic's CoreValve system in patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery.
FDA approves first transcatheter aortic valve in the USA
Edwards Lifesciences has received approval for the transfemoral delivery of the Sapien device for the treatment of inoperable patients with severe symptomatic aortic stenosis.
Genous stent is safe and effective in elderly patients
Twelve-month follow-up data from the e-HEALING (Healthy endothelial accelerated lining inhibits neointimal growth) registry shows that the Genous stent (OrbusNeich) is safe and effective in elderly patients. The study was published in Circulation.
FDA approves next-generation Xience Prime drug eluting stent for coronary artery disease
FDA approval of Xience Prime was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label study that met its primary endpoint with low rates of target lesion failure and stent thrombosis at one year.
FDA clears Ilumien system, the first and only combined FFR and OCT system
The combined fractional flow reserve (FFR) and optical coherence tomography (OCT) system from St Jude Medical offers physicians advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease.
NeoStem acquires Amorcyte, a clinical stage cardiovascular disease cell therapy company
NeoStem, intends to initiate, no later than the first quarter of 2012, a phase II clinical trial for Amorcyte's lead product candidate, AMR-001, for the treatment of acute myocardial infarction.
“Use of TAVI to increase in Europe as reimbursement becomes available in more countries”
Transcatheter valve implantation (TAVI) penetration rates are under 20% in Europe, according to data presented on 17 October at the PCR London Valves congress in London, UK.
Promus Element stent system launched in China
The Promus Element represents Boston Scientific's third-generation drug-eluting stent (DES) technology, which incorporates a novel platinum chromium (PtCr) alloy, innovative stent design and advanced catheter delivery system to treat coronary artery disease.
Gore acquires intellectual property of NMT Medical
Intellectual medical property from NMT includes the data related to CLOSURE I, a trial that may create better clinical understanding of patent foramen ovale in stroke patients.
Do drug-eluting stents increase the rate of late stent thrombosis compared to bare metal stents in STEMI patients? The DESERT cooperation
Giuseppe De Luca, Novara, Italy, comments on the results of the DESSERT (Drug-eluting stents in primary angioplasty) cooperation, a meta-analysis of randomised trials which aimed to evaluate the risks and benefits of drug-eluting stents in comparison to bare metal stents in patients undergoing primary percutaneous coronary intervention for STEMI.
APPOSITION I clinical study shows positive results for the Stentys Self-Apposing stent
"During the six-month follow-up period of the APPOSITION I study, there was no death, no stent thrombosis or reoccurrence of myocardial infarction, with revascularisation rates comparable to that of conventional stents," said Giovanni Amoroso, lead author of the study.
First patient treated in Cardiac Dimension’s TITAN II clinical trial
TITAN II is a prospective, single-arm clinical trial initiated to further evaluate an enhanced version of the Carillon system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation.
Medtronic to start trial for Engager transcatheter aortic valve implantation system for severe aortic stenosis
The Engager transapical valve is comprised of bovine tissue leaflets and a self-expanding nitinol frame designed to facilitate accurate positioning and stability when implanted.
Increased risk of death is not associated with same-day discharge after elective PCI
A new JAMA study shows that same-day discharge of selected low-risk Medicare patients who underwent an elective percutaneous coronary intervention (PCI) was not associated with an increased risk of being rehospitalised or having a higher risk of death at two days or at 30 days.
Boston Scientific begins patient enrolment for Omega platinum chromium stent system
The primary endpoint of the OMEGA trial is nine-month target lesion failure, a composite measure that includes target lesion revascularisation, myocardial infarction and cardiac death in patients with a single coronary artery lesion.
Prasugrel or ticagrelor should be administered to patients at clinical high risk for stent thrombosis
Dean J Kereiakes, USA, comments on the results from the PLATO and TRITON-TIMI 38 trials which randomised patients with acute coronary syndromes to get treatment with either ticagrelor (PLATO) or prasugrel (TRITON-TIMI 38) in comparison to clopidogrel.
“This is a very good time to hop on the wagon and learn about 3D echocardiography”
Roberto M Lang, past president of the American Society of Echocardiography, spoke to Cardiovascular News about the use of 3D echocardiography and the future of the technique.
Abbott initiates patient enrolment in the EXCEL trial for unprotected left main coronary artery disease
EXCEL is the largest, multicentre, randomised trial to assess the safety and efficacy of the Xience Prime/Xience V everolimus eluting coronary stent systems (Abbott), compared to coronary artery bypass grafting (CABG), or surgery, in select patients with unprotected left main coronary artery disease.
JenaValve receives CE mark for second-generation transapical TAVI system
"The JenaValve design allows the cardiac surgeon and cardiologist to achieve precise positioning and allows repositioning of the heart valve prosthesis with its unique, patented positioning feelers," according to Friedrich-Wilhelm Mohr, principal investigator of the transapical TAVI system's CE-marking study.
Heart failure patients benefit from MitraClip therapy, PERMIT-CARE trial shows
"Results of this study suggest that MitraClip treatment could offer, for the first time, a solution for heart failure patients who have severe mitral regurgitation and are unresponsive to CRT," according to Angelo Auricchio, lead investigator of the study.
Carillon mitral contour system receives CE mark
Utilising the heart's natural structures, Carillon (Cardiac Dimensions) is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation.
Boston Scientific begins enrolment in NECTAR-HF clinical trial
NECTAR-HF is a prospective, randomised, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients.
HeartWare reports updated clinical data from the ADVANCE trial at EACTS meeting
The ADVANCE clinical trial is an IDE FDA approved study designed to evaluate the HeartWare Ventricular Assist system as a bridge to heart transplantation for patients with advanced heart failure.
Getinge Group and subsidiary Maquet Cardiovascular sign agreement to acquire Atrium Medical
Atrium is a leader in medical device technologies for interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and general surgery.
BDC Laboratories, Blockwise Engineering to collaborate on stent and transcatheter heart valve testing
Blockwise Engineering segmented test stations uniformly radially load a stent or transcatheter heart valve frame with minimal friction to facilitate an accurate measure of the test articles radial resistive force.
VentriPoint initiates multicentre clinical trial to validate VMS 3D imaging technology
The trial for the VMS 3D system will explore this imaging technology in patients with Tetralogy of Fallot or Blue-baby Syndrome.
New genes identified for coronary artery disease and heart attacks
Nilesh Samani, co-principal investigator of the new study published in PLoS Genetics, said, "The findings provide new insights into and understanding of the causal biological pathways that cause heart disease, and particularly highlight the role of lipids and inflammation."
Sensation Plus 50cc 8Fr. intra-aortic balloon catheter gets CE mark and FDA approval
This is the first catheter combining fiber optic signal acquisition with greater haemodynamic support compared to a standard 40cc intra-aortic balloon catheter.
enCorSQ mitral valve repair system gets CE mark
The enCorSQ device (MiCardia) is surgically implanted to treat mitral regurgitation and enables physicians to adjust it without another surgery to correct any recurrent mitral valve regurgitation that may occur due to the progressive nature of the underlying cardiovascular disease.
Stentys self-apposing stent has been implanted in more than 1,000 patients
The self-apposing feature of the Stentys stent ensures optimal apposition during thrombus and vessel spasm relief in the critical initial hours and days after an acute myocardial infarction procedure.
Ticagrelor associated with fewer cardiac, bleeding and infection complications as compared to clopidogrel
A blinded review of the PLATO trial data found that ticagrelor was associated with fewer complications that directly caused or contributed to death following coronary artery bypass graft surgery.
Stenting shows more major adverse events than bypass grafting in complex patients at three years
The rate of major adverse cardiac and cerebrovascular events is significantly higher with percutaneous coronary intervention in patients with left main or three-vessel disease, according to the SYNTAX trial.
Martyn Thomas
Martyn Thomas, clinical director of Cardiology and Cardiothoracic Services, St Thomas' Hospital, London, UK, is an enthusiast of transcatheter aortic intervention. In this interview, he told Cardiovascular News why he believes TAVI will be the dominant technology for aortic stenosis within the next 10 years.
Pioneer of interventional cardiology in China receives Ethica Award 2011
Run-Lin Gao, described as "the father of interventional cardiology in China" spoke to Cardiovascular News about the Ethica Award recognition, the development of interventional cardiology in China, and the 10th China Interventional Therapeutics (CIT) conference, taking place in Beijing in March 2012.
NICE draft guidance recommends use of new generation cardiac CT scanners
The recommendation is for first line imaging of the coronary arteries in people with suspected stable coronary artery disease who are difficult to image with earlier generation CT scanners and whose estimated probability of having coronary artery disease is 10-29%.
British Heart Foundation awards £1.1M to Andrew Baker for research on coronary heart disease
The Award will help Baker from the University of Glasgow and his team to develop treatments for patients suffering from coronary heart disease and related complications.
Miracor secures US$10M financing round to develop RAMSES clinical trials and strengthen product sales
The financing will support enrolment into the post CE mark RAMSES trials of Miracor's PICSO technology used during coronary revascularisation procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system.
Mesoblast receives European clearance to begin trial of allogeneic stem cell treatment for heart attacks
The placebo-controlled phase II AMICI trial will evaluate the safety and efficacy of Revascor (Mesoblast), an allogeneic or "off-the-shelf" adult stem cell product used in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack.
ESC guidelines recommend prasugrel for patients with NSTEMI and unstable angina
The highest available recommendation, Class I recognises that prasugrel is considered a "beneficial, useful and effective" treatment option for first-line use in these patients.
Everolimus-eluting stent shows encouraging results in STEMI patients
When compared to a bare metal stent, the drug-eluting device demonstrated lower rates of target vessel and lesion revascularisation and stent thrombosis in the EXAMINATION trial.
Prolonged antiplatelet therapy no better than six-month regimen
In the PRODIGY study, 2,000 coronary angioplasty patients were randomised to receive either six or 24 months of dual antiplatelet treatment.
Exposure of physicians to radiation prompts cellular changes that may protect the body from harm
New research has found the first evidence that high levels of ionising radiation exposure cause changes at cell level that might represent the body's way of protecting itself against the harmful effects of radiation.
ESC sets consensus over TAVI
The annual meeting of the European Society of Cardiology, in Paris, has enhanced the status of TAVI as the "gold standard" for inoperable patients suffering from severe aortic stenosis. However, concerns about high rates of permanent pacemaker implantation after TAVI remain, specialists say.
Barostim neo is CE marked for the treatment of uncontrolled hypertension
The Barostim neo uses CVRx-patented technology that is designed to trigger the body's own natural blood flow regulation system by electrically activating the baroreceptors to treat high blood pressure.
Panel publishes advisory on diagnosing and managing patients with chronic heart failure and anaemia
The panel supports the introduction of intravenous iron – which can be given over a short period of time and is well-tolerated – as a more attractive therapy option to oral iron or erythropoiesis-stimulating agents.
RE-ALIGN trial to start evaluation of dabigatran etexilate in patients with mechanical heart valves
The 12-week study sponsored by Boehringer Ingelheim will compare three doses of dabigatran etexilate (150mg bid, 220mg bid and 300mg bid) to warfarin in patients with both aortic valve replacements and mitral valve replacements.
“The lower the heart rate, the better the quality of life,” SHIFT study shows
New results from SHIFT (Systolic heart failure treatment with the If inhibitor ivabradine trial), the largest-ever morbi-mortality study of treatments for chronic heart failure, reveal for the first time a direct link between heart rate reduction and quality of life in patients with heart failure.
European Society of Cardiology launches upgraded risk measurement tool for heart attacks and strokes
Three variants of the updated HeartScore have been formally released at the 2011 ESC Congress in Paris. The new features improve accuracy of the tool.
High baseline resting heart rate is associated with a higher prevalence and severity of angina and heart attacks, CLARIFY registry confirms
Results from the CLARIFY registry show that 44% of the coronary artery disease outpatients had a resting heart rate greater than or equal to 70 bpm, a rate that has previously been shown to be linked with higher prevalence and severity of angina and with more frequent evidence of ischaemia.
New CT scan may speed up heart disease diagnosis with less radiation
In preliminary tests from a small trial of 39 patients, computerised tomography (CT) scans called 2nd generation 128 Slice Dual Source "Flash" CT captured quicker images of the entire heart, allowing doctors to better see artery blockages and reduced blood flow through the heart.
New NICE guideline will radically change how high blood pressure is diagnosed
The guideline makes a number of new recommendations that are set to improve the way professionals diagnose and treat high blood pressure in in England and Wales.
Coronary artery stenting viable palliative option for infants and toddlers
A study led by András Bratincsák from Rady Children's Hospital in San Diego, USA, conducted a review of seven children who underwent intervention between June 2006 and June 2010.
TRIAS two-year follow-up data show no stent thrombosis with Genous stent
Results from the randomised pilot study showed no significant difference in target vessel failure between Genous and a drug-eluting stent in patients with de novo lesions carrying a high risk for restenosis.
Use of the Genous stent in patients with atrial fibrillation
Sigmund Silber, of the Kardiologische Klinik Dr Müller, Munich, Germany, discusses the benefits of using the Genous Bio-engineered R stent in patients with atrial fibrillation.
No erosion associated with the Gore Helex Septal Occluder
First used in Europe in 1999 and approved by the FDA in 2006, the occluder is composed of ePTFE patch material supported by a single nitinol wire frame.
First patient treated in Japan with Abbott’s Absorb BVS
This bioresorbable vascular scaffold (BVS) can treat a patient's blocked heart vessel and then dissolve within two years, leaving the vessel free of a permanent metallic implant. The treatment of the patient in Japan is part of the ABSORB EXTEND global clinical trial.
Medtronic receives CE mark for 31mm CoreValve percutaneous aortic valve
The CoreValve system is the only transcatheter aortic valve available in the world that can treat, without surgery, patients with larger valve openings (up to 29mm).
University of Münster bridges first patient to transplant with SynCardia’s Total Artificial Heart
The University of Münster in Germany has successfully bridged its first patient to transplant with the Total Artificial Heart after 89 days of support.
Edwards lifesciences launches physio tricuspid heart valve repair ring
Carpentier-Edwards physio tricuspid annuloplasty ring features a three-dimensional waveform shape which allows the ring to conform to the natural shape of a patient's tricuspid annulus during valve closure.
Estrogen could help protect women from cardiovascular disease, new research shows
The sex hormone estrogen could help protect women from cardiovascular disease by keeping the body's immune system in check, new research from Queen Mary, University of London, UK, has revealed.
10 milllion patients diagnosed with ACIST contrast delivery system
The system used in cardiovascular angiography, "shortens procedures, decreases the amount of dye injected into patients and reduces radiation exposure for health care professionals and patients," Robert Wilson, ACIST system inventor, states.
Siemens improves its angiography systems with navigation technology from St. Jude Medical
This technology has great potential to save radiation dose during long electrophysiology procedures as the patient does not need to be scanned repeatedly with the angiography system in order to track the catheter.
First renal denervation treatment for resistant hypertension performed in Latin America
The first use of Medtronic’s Symplicity, a minimally invasive, catheter-based procedure for the treatment of resistant hypertension, occurred on 4 August 2011 at Clinica Santa Maria in Santiago, Chile.
FDA approves RX Herculink Elite renal stent system for treatment of renal artery disease
Renal stenting with Abbott Vascular's RX Herculink Elite system is safe and significantly reduces blood pressure at nine months, finds the HERCULES study.
Stem cell researchers uncover reason why the adult human heart cannot regenerate itself
Adult human cardiac myocytes have lost their ability to proliferate, perhaps explaining why the human heart cannot regenerate itself, stem cell researchers from the University of California, Los Angeles (UCLA) found.
Transcatheter aortic valve replacement case, Cleveland Clinic
An 81-year-old woman with severe symptomatic aortic stenosis undergoes TAVI at the Heart and Vascular Institute.
Clinical vs. anatomical risk stratification following complex PCI
Ralf Lehmann, Frankfurt, Germany, explains how a combination of clinical and anatomical risk factors may provide the optimal predictive model in patients undergoing multivessel percutaneous coronary intervention.
“There is a great deal of excitement about renal denervation among interventional cardiologists”
Deepak L Bhatt, principal investigator of the SYMPLICITY HTN-3, told Cardiovascular News what the principles behind renal denervation are, outcomes from previous trials and the design of the ongoing SYMPLICITY HTN-3 study.
Revascularisation options in diabetic patients with multivessel disease
Robert Harrington, Duke University Medical Center, is interviewed on diabetes and multivessel coronary artery disease
Pradaxa (dabigatran etexilate) gets approval for stroke prevention in AF patients in Europe
For the first time in 50 years, the approval of this oral anticoagulant gives AF patients access to a new treatment for the prevention of AF-related strokes in Europe.
Promising early results with new transapical TAVI device
At six months, Acurate TA (Symetis) demonstrated an 87.5% survival rate, a perivalvular leak rate of 0–1 in 97% of the followed patients and functional improvement from baseline in 90% of the cases with a NYHA Class I/II, Joerg Kempfert told delegates at EuroPCR, Paris, France.
Bioengineered stent safe and effective in cases where prolonged dual antiplatelet therapy is not advisable
Data from multiple clinical trials using the OrbusNeich Genous stent were featured during the Healing Symposium at EuroPCR 2011 in Paris, France.
FDA recommends approval of Edwards Sapien transcatheter valve
FDA's Advisory Panel voted on 20 July 2011 to recommend approval of the Sapien transcatheter heart valve (Edwards Lifesciences) for the treatment of certain inoperable patients.
Mitroflow aortic pericardial heart valve gets CE mark
Mitroflow (Sorin) contains a proprietary advanced tissue treatment with phospholipid reduction properties which is intended to prevent the potential calcification of the Mitroflow bioprosthetic valve.
Resolute drug-eluting stent superior than Taxus drug-eluting stent, Japanese study shows
The Resolute drug-eluting stent (Medtronic) showed superiority to Taxus drug-eluting stent (Boston Scientific) on the primary endpoint of the RESOLUTE Japan clinical study: in-stent late lumen loss at eight months.
FDA approves Brilinta (ticagrelor)
The FDA approval is based upon data from the PLATO study, which shows that Brillinta reduces the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel.
Neutralisable anticoagulant found to be well tolerated in healthy subjects, study shows
EP217609 and its specific antidote avidin (Endotis Pharma) were found to be well tolerated in phase I studies. Data were presented at the XXIII Congress of the International Society on Thrombosis and Haemostasis (Kyoto, Japan, 23-28 July 2011).
Renal denervation improves glucose metabolism
Peter Block says renal denervation, which has captured the imagination of interventionalists, has shown to improve glucose metabolism.
Cardinal Health launches molecular imaging collaboration center
The Center is the first-of-its-kind collaboration laboratory that will expedite the development of nuclear imaging agents to treat complex diseases like cancer, heart disease and neurological disorders.
Genous stent is safe to use after early discontinuation of dual antiplatelet therapy
Data from high-risk patients requiring early discontinuation of dual antiplatelet therapy due to non-deferrable, non-cardiac surgery show good short and long-term safety outcomes following treatment with the Genous stent (OrbusNeich).
St. Jude Medical’s diagnostic technology receives CE mark
The Ilumien system combines optical coherence tomography and fractional flow reserve technologies on one platform to improve the diagnosis and treatment of coronary artery disease.
CryoLife makes equity investment in ValveXchange
Under the agreement, CryoLife will receive an approximate 19% initial equity ownership in ValveXchange.
Lantheus Medical Imaging initiates phase III clinical trial of Flurpiridaz F 18 for the detection of coronary artery disease
The open-label, multicentre study will evaluate the diagnostic efficacy of flurpiridaz F 18 PET myocardial perfusion imaging (MPI), compared with single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease.
FDA clears EV1000 clinical monitoring platform
The EV1000 clinical monitoring platform (Edwards Lifesciences) displays real-time information about a patient's haemodynamic status simplifying decision-making in the operating room and intensive care unit.
Biotronik announces first patients treated in BIOFLOW-II clinical study
BIOFLOW-II is a prospective international trial that will randomise approximately 440 patients with Orsiro (Biotronik) or Xience Prime (Abbott) in a two-to-one manner at 19 European sites.
InfraReDx initiates CANARY clinical trial of LipiScan IVUS coronary imaging guidance
CANARY is designed to test the hypothesis that near-infrared guided use of an embolic protection device, during percutaneous coronary intervention can reduce the rate of peri-procedural heart attacks in patients identified as having high-risk lipid core plaques.
Identifying an alternative to drug-eluting stents for treating bifurcation lesions
Coronary bifurcation lesions make up 15% to 20% of PCIs and remain a challenge for cardiologists due to the complexity of the lesions and the increased frequency of associated adverse events, Marcel Beijk writes to Cardiovascular News.
PCI shows promising results in patients with infarction and thrombosis of the unprotected left main coronary artery
At one-year follow-up, in-hospital survivors had a mortality rate of 10.5%, whereas 18.4% experienced subsequent major adverse cardiac events.
Non-invasive FFR superior to CT angiography for diagnosis of lesion-specific ischaemia
Results from non-invasive fractional flow reserve combined with computed tomography (FFR-CT) were presented by Bon-Kwon Koo in a Late-Breaking Trials session at EuroPCR.
SynCardia’s Total Artificial Heart presented at TechConnect World Summit
Marvin J Slepian, University of Arizona, USA, discussed the technical and clinical status of the world's only FDA, Health Canada and CE approved total artificial heart at the TechConnect World Summit, Boston, USA, on 14 June 2011.
Micell Technologies reduces clinical trial sample size for MiStent drug-eluting coronary stent based on early clinical data
Based on results observed in the DESSOLVE I trial, Micell has reduced the sample size in its DESSOLVE II CE mark study from 270 to 171 planned subjects.
NICE recommends use of Brilique (ticagrelor) in patients who have had a heart attack or episode of unstable angina
The National Institute for Health and Clinical Excellence (NICE) has recommended ticagrelor (AstraZeneca) in combination with aspirin as a treatment option in adults with acute coronary syndromes.
New NICE quality standards published on chronic heart failure
NICE published, on 30 June 2011, quality standards for the assessment, diagnosis and clinical management of chronic heart failure in adults, adding to the bank of quality standards already completed.
ESC calls for greater awareness of potential for adverse events from bleeding as a result of percutaneous coronary intervention
The European Society of Cardiology (ESC Working Group on Thrombosis) is calling for greater attention to be paid by health care staff to reducing bleeding in patients with acute coronary syndromes undergoing percutaneous coronary interventions, and for increased research in the field.
Positive results for unprotected left main coronary artery PCI with drug-eluting stents
Intervention is Viable Option for Low-Risk Patients with Normal Function in Left Ventricle, according to a paper published in Catheterization and Cardiovascular Interventions.
ESC calls for renaming of term cardiac hypertrophy
In a paper published in the European Journal of Heart Failure, the ESC Working Group on Myocardial Function suggests the use of the general term myocardial remodelling.
SeptRx begins CE mark trial of intrapocket PFO occluder
The first implants have been completed in the InterSEPT trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, Germany, under principal investigator Horst E Sievert.
Pitavastatin demonstrates sustained increases in HDL-C and offers atheroprotective benefits
The LIVES study extension showed a relationship between on-treatment serum HDL-C levels and cardiovascular risk, and that pitavastatin provided elevations in HDL-C that continued to increase over five years.
Ticagrelor reduces cardiovascular events and deaths compared to clopidogrel
Data from the PLATO trial showed that acute coronary syndrome patients, who were intended to follow a non-invasive treatment plan, had fewer events without an increase in bleeding with ticagrelor.
Cappella Medical introduces new longer Sideguard coronary sidebranch stents
The new stent sizes have a 14mm working length which is 75% longer than the existing Sideguard stents.
Drug-eluting coronary stents using biodegradable polymer significantly improve overall clinical outcomes
Drug-eluting coronary stents with a biodegradable polymer significantly improve overall clinical outcomes and reduce stent thrombosis by 50% compared with drug-eluting coronary stents using a durable polymer over a three-year period. These were the findings from a new independent patient-level meta-analysis involving over 4,000 patients, presented at EuroPCR.
Cordis will stop developing drug-eluting coronary stents
"Due to evolving market dynamics in the drug-eluting stent business, we see greater opportunities to benefit patients and grow our business in other areas of the cardiovascular device market," said Seth Fischer, company group chair and worldwide chairman, Cordis.
Rapiscan (regadenoson) is launched in the United Kingdom
Rapiscan is a new generation pharmacological stress agent for myocardial perfusion scintigraphy in adult patients unable to undergo adequate exercise stress in the diagnosis of coronary artery disease.
APOLLO trial shows sustained benefits at 18 months in cardiac cell therapy
Reduction in infarction, improvement in perfusion of the left ventricle and fewer premature ventricular beats were shown in the randomised, placebo-controlled, double-blind safety and feasibility US trial.
First implant of St Jude Medical’s Portico transcatheter heart valve
The device can be completely resheathed and retrieved before it is released from the delivery system, allowing physicians to reposition the valve at the implant site.
CoreValve study shows rapid and sustained health-related quality-of-life improvements
Two-year results of 126 patients from Europe and Canada were presented at the EuroPCR congress in Paris.
Favourable clinical study results reported with dual antiplatelet therapy after left atrial appendage closure with Watchman device
A German experience with the device was presented by Martin Bergmann, Department of Cardiology at the Asklepios Klinik St. Georg in Hamburg at the EuroPCR congress in Paris.
Juventas Therapeutics completes phase I clinical trial for JVS-100
JVS-100 is intended to be used in the treatment of patients with heart failure. JVS-100 encodes Stromal-cell Derived Factor 1 (SDF-1), which promotes cardiac repair following a myocardial infarction through activation of natural stem-cell repair pathways.
FDA approves Trifecta valve
St. Jude Medical's valve is a clinically-proven replacement for diseased, damaged or malfunctioning aortic heart valves; it has been designed to optimise the blood flow through the valve and has long-term durability.
LipiScan IVUS coronary imaging system receives CE mark
The system includes the world's first and only cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterise lipid core coronary plaques.
FDA approves ION Platinum Chromium stent system
Boston Scientific's system incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
Absorb shows positive one-year safety and efficacy results
One-year results from 101 patients enrolled in the second phase of the ABSORB trial evaluating the world's first drug-eluting Bioresorbable Vascular Scaffold (BVS) for the treatment of coronary artery disease were presented at the American College of Cardiology's Scientific Session in New Orleans, USA.
PARTNER finds TAVI as good as surgery
In patients with aortic stenosis at high risk for surgery, TAVI with the Sapien transcatheter aortic valve (Edwards Lifesciences) was non-inferior to surgical aortic valve replacement for all-cause mortality at one year, 24.2% vs. 26.8%, respectively, according to data presented by Craig R Smith at the American College of Cardiology's Scientific Session in New Orleans, USA.
GATEWAY Registry: Addressing bleeding risk in patients with acute coronary syndrome
David Smith, principal investigator of the GATEWAY Registry trial, spoke to Cardiovascular News on treatment for acute coronary syndrome patients, their bleeding risk complications from receiving antiplatelet therapy and the GATEWAY Registry that seeks to address this risk.
First ESC/EACTS guidelines on coronary revascularisation
Eduardo AlegrÃa Barrero, Cardiology and Cardiovascular Surgery, Rotger Clinic, Palma de Mallorca, Spain, and Eduardo AlegrÃa Ezquerra, Cardiology and Cardiovascular Surgery, Guipuzcoa Policlinic, San Sebastian, Spain, explained the first ESC/EACTS guidelines on myocardial revascularisation.
Roberto Ferrari
Roberto Ferrari, professor of Cardiology at the University of Ferrara, Italy, has recently concluded his term as president of the European Society of Cardiology. He spoke to Cardiovascular News about his current areas of research and his achievements as ESC president.
Ralph Brindis
Ralph Brindis, president of the American College of Cardiology (ACC) 2010–2011, spoke to Cardiovascular News about his career, greatest influences, the National Cardiovascular Registry and his efforts as a swimmer for the University of San Francisco Master's Swim team.
Abbott launches MitraClip system in Australia
This system is the world's first-of-its-kind percutaneous minimally invasive treatment option for patients suffering from mitral regurgitation.
EVEREST II study demonstrates MitraClip’s durable clinical benefits for patients with mitral regurgitation, two years after treatment
This is the first randomised clinical trial, in the United States and Canada, to compare a catheter-based mitral valve device to mitral valve surgery. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology's (ACC) 60th Annual Scientific Session.
Medrad Interventional introduces next generation Fetch2 aspiration catheter
The new Fetch2 is a manual aspiration device that has the ability to quickly resolve small, fresh thrombus in the coronary arteries.
GE Healthcare IT and TomTec work together to enhance cardiology patient care
Their collaboration will provide clinicians with advanced tools for review of echocardiography and vascular images, and could enhance the speed and accuracy of diagnosis within the non-invasive cardiovascular clinical space.
CardioNexus introduces CardioHealth Station at ACC Sesions 2011
The FDA cleared station is an automated and portable cardiovascular imaging device which enables physicians, especially primary care physicians and internists, to perform atherosclerosis imaging and cardiovascular risk assessment in their offices, without need for outside referral.
Platelet inhibition of PA32540 shows superior results over a standard of care regimen
Data from the phase I Co-Rx study suggest that a novel coordinated-delivery tablet of enteric-coated aspirin and immediate-release omeprazole (PA32540) given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in significantly better inhibition of ADP-induced platelet aggregation when compared to a current standard of care.
New EAE position statement tries to tackle misuse of pocket-size echo devices
The European Association of Echocardiography (EAE) released a position statement on the use of pocket-size imaging devices in January 2011. Cardiovascular News spoke to Rosa Sicari, one of the authors of the paper published in the European Journal of Echocardiography.
Triple antiplatelet therapy reduces restenosis in long lesions after drug-eluting stent implantation
Results of the DECLARE-LONG II trial show triple antiplatelet therapy decreased late lumen loss and restenosis after the implantation of long zotarolimus-eluting stents, resulting in a reduced risk of 12-month target lesion revascularisation compared with dual antiplatelet therapy.
A fifth of ACS treated patients develop major cardiac events within three years
Between 2004 and 2006, 697 patients with acute coronary syndromes were enrolled at 37 sites in the United States and Europe after undergoing successful percutaneous coronary intervention. Results of the PROSPECT study were published in The New England Journal of Medicine.
Coronary artery calcium scans may help patients lower heart disease risk
A new study of coronary artery calcium scanning, a simple, noninvasive test that gives patients baseline information about plaque in their coronary arteries has shown that the scan helps them make heart-healthy lifestyle changes and lower their heart disease risk factors.
NICE releases guidance to use hypothermia as a treatment option after cardiac arrest
This new guidance advises that healthcare professionals could consider therapeutic hypothermia as a treatment option for people who are at risk of brain injury after cardiac arrest, under their hospital's usual arrangements for clinical audit/research, governance and consent.
Omega Platinum Chromium Coronary Stent System is implanted for the first time in the UK
This system incorporates a unique platinum chromium (PtCr) alloy and provides interventional cardiologists a bare-metal stent with improved acute performance in treating patients with coronary artery disease.
University of Michigan Cardiovascular Center participates in the CoreValve clinical trial
Medtronic's CoreValve US pivotal clinical trial will examine an investigational alternative to open heart surgery for patients with severe aortic stenosis.
OrbusNeich launches its Azule Cobalt Chromium stent
Azule features OrbusNeich's unique Dual Helix stent design, offering conformability and radial strength on thin, flexible and low-profile cobalt chromium stent struts.
Edwards Lifesciences acquires Embrella Cardiovascular
Embrella Cardiovascular is the developer of the Embrella Embolic Deflector System, product designed to reduce the amount of embolic material that may enter the carotid arteries during endovascular procedures.
Stentys expands operations into four additional European countries
Stentys, a developer of stents to treat acute myocardial infarction, will be commercialising its products in Scandinavia, Spain, Switzerland and Poland.
Lantheus Medical Imaging receives FDA’s special protocol assessment for phase III clinical trial of flurpiridaz F-18
Flurpiridaz F-18 has the potential to be a new clinical tool for the evaluation of myocardial perfusion that may better evaluate patients with known or suspected coronary artery disease.
Medtronic launches Contour 3D Annuloplasty Ring for the treatment of tricuspid valve disease
The new heart valve repair ring is designed to restore normal valve function by remodeling the natural valve's shape and size.
Ziehm Imaging launches hybrid edition mobile C-arm
The new generation of the Ziehm Vision RFD mobile C-arm offers outstanding imaging and a liquid cooling system which allows it to be used over an almost unlimited period of time, this new version is an attractive choice for hybrid operating rooms (ORs).
Pfizer Health Solutions launches OwnHealth Choice
Innovative telephone based self care programme for patients with long-term conditions associated with significant reductions in hospital stay and patient care costs.
Edwards receives CE mark approval for a larger version of its Sapien XT transcatheter aortic valve
This transcatheter valve enables clinicians to replace failing aortic valves with a minimally invasive procedure.
Boston Scientific completes acquisition of Atritech
Atritech's Watchman Left Atrial Appendage Closure Technology gives Boston Scientific an innovative product designed for atrial fibrillation patients with high stroke risk.
New dual drug-eluting stent effective in decreasing in-stent late loss
A new drug-eluting stent has been designed to increase the antirestenotic performance of the paclitaxel-eluting stent and decrease the risk of stent thrombosis by incorporating cilostazol, according to Seung-Jung Park and colleagues at Asan Medical Center in Seoul, South Korea.
One third of TAVI patients require permanent pacemaker within 30 days
Two studies recently published have found that a high number of Corevalve implant patients require a permanent pacemaker shortly after the procedure.
COSIRA trial begins patient enrolment to treat refractory angina
The Neovasc Reducer, COSIRA's device under study, is designed to establish a permanent and controlled narrowing of the coronary sinus.
Omega Platinum Chromium Stent System is approved in Europe
Boston Scientific's third-generation bare metal stent offers improved acute performance in treating patients with coronary artery disease.
Eagle Eye Platinum Digital IVUS catheter receives Japanese clearance
This intravascular ultrasound catherer offers improved deliverability and additional radiopaque markers to accurately perform angiographic lesion length assessments.
Nile Therapeutics to collaborate with Medtronic on clinical development of cenderitide for heart failure and renal disease
Medtronic will fund and provide its drug-device expertise as Nile executes on its phase I clinical trial to assess the pharmacokinetics and phamacodynamics of cenderitide delivered through Medtronic diabetes pump technology.
SCAI publishes statement on standards for quality assessment and improvement in interventional cardiology
This is the first document offering guidance regarding core measures for quality and assessment in percutaneous coronary intervention programmes.
Next-generation Sapphire II coronary dilatation catheter is commercially available
This balloon catheter is designed to penetrate severely narrowed lesions and tortuous anatomies.
Medtronic’s Mosaic heart valve demonstrates long-term durability up to 12 years in international study
The study revealed freedom from structural valve deterioration in 93.3% of aortic valve replacement patients and in 95.3% of mitral valve replacement patients.
e-HEALING registry shows positive clinical outcomes for OrbusNeich’s Genous Stent
Target lesion revascularisation was 5.7% and stent thrombosis was 1.1%, these were some of the results published in the February issue of EuroIntervention.
Micell Technologies enrolls first patient in DESSOLVE II clinical trial
This clinical investigation is being conducted to support CE mark approval of the company's MiStent drug-eluting coronary stent (DES) system.
Boston Scientific launches Promus Element and Taxus Element Stent Systems in India
India is one of the fastest-growing drug-eluting stent markets in the world, with the number of coronary drug-eluting stents implanted annually estimated at more than 150,000. In 2010, the company received approval from the Drugs Controller General of India to market these systems.
Registry for CoreValve system confirms positive clinical outcomes
The Registry shows that patients receiving the CoreValve system (Medtronic) have high rates of procedural success (98%), low rates of adverse events (2.1%) and substantial improvements of cardiac function. The study results were published online in the journal Circulation.
Registry will investigate the Genous stent in patients with acute coronary syndrome and high-risk of post-procedural bleeding
GATEWAY registry will assess the performance of the device in providing anti-ischaemic protection while providing bleeding safety by the use of shortened dual antiplatelet therapy.
The SOURCE registry in the context of PARTNER
Olaf Wendler and Martyn Thomas compare the results of the PARTNER randomised trial with those of the SOURCE European registry and speculate on reasons for differences in outcomes.
New absorbable stent era begins
Experts tell Cardiovascular News why it is too early to conclude what the role of absorbable devices will be and explain what still needs to be investigated.
CE mark for Peripatch-BV bovine pericardial tissue
PeriPatch-BV (Neovasc) products are used in a variety of general surgical and cardiovascular applications and as components in implantable heart valves and other medical devices.
SCAI publishes consensus document about radiation exposure to the pregnant interventional cardiologist and technical staff
The aim of this paper is to provide an overview of the true risk of radiation exposure in pregnant practitioners who perform cardiac catheterisation procedures and best practice guidance to reduce radiation exposure.
Vascular Solutions acquires Zerusa Ltd, manufacturer of the Guardian haemostasis valves
The acquisition price of €3.15 million (US$4.3 million) is paid from existing cash balance.
FDA announces cardiovascular risks added to rosiglitazone (Avandia) labels
The FDA also informed that rosiglitazone's labels advice that the drug should only be used in patients already being treated with these medicines and in patients whose blood sugar cannot be controlled with other anti-diabetic medicines.
New imaging modality receives CE mark
The Ingenuity TF PET/MR (Philips) is used to screen patients at high-risk for heart disease to ultimately treat diseased cells prior to the formation of dangerous coronary plaques.
FDA gives conditional approval for pivotal study to evaluate robotic-assisted placement of coronary guidewires and stent/balloon catheters
The clinical endpoint of the trial is the ability to treat the patient without the incidence of major adverse cardiovascular events, also to monitor the radiation exposure of interventional cardiologist while using the CorPath (Corindus) technology.
Boston Scientific begins clinical trial enrolment in China for Promus Element everolimus-eluting stent
PLATINUM China clinical trial is designed to evaluate the safety and effectiveness of the Element stent in the treatment of patients with a single de novo atherosclerotic lesion.
Bio-engineered stent safe in high-risk patients with contraindications for dual antiplatelet therapy
In the study, the major adverse cardiac events free survival rate in patients treated with the Genous stent, from OrbusNeich, was 80.6% after one year.
Xience Prime receives the CE mark for treatment of critical limb ischaemia in the lower limb
Data generated on the Xience V drug-eluting stent from the DESTINY trial supported the CE marking. Marc Bosiers, principal investigator of the trial, concluded that the use of everolimus-eluting stents can potentially provide significantly better outcomes for patients with critical limb ischaemia in the lower leg.
It is time for a SYNTAX-like trial for transcatheter valves
Pieter Kappetein explains how the SURTAVI trial will use the same SYNTAX trial concept, with a heart team deciding which patients can be randomised to transcatheter aortic valve implantation (TAVI) with the CoreValve device or to surgical aortic valve replacement.
Occurrence of stroke after coronary artery bypass graft surgery appears to be decreasing, study shows
Khaldoun G. Tarakji and colleagues, researches of the study, concluded that occurrence of stroke among patients undergoing coronary artery bypass graft has decreased over the last 3 decades despite an increasing patient risk profile.
SCAI publishes radiation safety programme principles for cardiac catheterisation labs
The paper titled "Radiation safety program for the cardiac catheterization laboratory" includes recommendations designed to enhance patient and staff safety in cardiac procedures involving radiation.
Volcano’s IVUS and VH IVUS technologies can assess the risk of individual blockages better than the use of the current standard of care angiographic imaging alone, PROSPECT study shows
The study published in The New England Journal of medicine also showed that differences in underlying tissue type can change the risk profile of a lesion.
Boston Scientific completes enrollment in EVOLVE clinical trial to evaluate Synergy drug-eluting coronary stent
The Synergy drug-eluting stent is designed to provide the same degree of restenosis reduction as a conventional drug-eluting stent while offering faster and more complete vessel healing after stent implantation.
Medtronic revises design of CoreValve US pivotal trial
The CoreValve system is designed to provide a minimally invasive, non-surgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery.
St. Jude Medical announces launch of the ViewMate Z intracardiac ultrasound system and ViewFlex Plus ICE catheter
The new intracardiac ultrasound and intracardiac echocardiography (ICE) system offers real-time image guidance, visualisation of cardiac anatomy and great portability.
Minimal differences in the use of radial artery graft and saphenous vein graft for coronary artery bypass grafting
A multicenter, randomised controlled trial conducted from February 2003 to February 2009 among 757 participants undergoing first-time elective coronary artery bypass grafting showed insignificant differences in the use of radial artery and saphenous vein grafts.
AccessClosure announces launch of new Mynx Cadence vascular closure device
The next generation device offers physicians smoother device deployment while maintaining all the benefits of the original Mynx.
World’s first drug-eluting bioresorbable stent receives the CE mark
The Absorb device, from Abbott, can treat blocked coronary arteries and then dissolve, leaving the patient's vessel free of a permanent metallic implant.
Boston Scientific completes acquisition of Sadra Medical
Boston Scientific paid US$193 million to acquire the remaining 86% of Sadra Medical's equity.
First patient is enrolled in US pivotal study of the Tryton Side Branch Stent
Indulis Kumsars, chief of the catheterisation laboratory at Pauls Stradins Clinical University Hospital in Riga, Latvia, enrolled the first patient.
HeartWare files FDA pre-market approval application of HeartWare Ventricular Assist System
The ADVANCE trial demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days with the device.
Meril Life Sciences’ Biomime sirolimus-eluting stent receives the CE mark
The stent is built on an ultra-low strut thickness (65µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion.
Miracor receives CE mark for the PICSO Impulse System
The new device is designed to improve acute coronary syndrome revascularisation following primary percutaneous coronary intervention.
Landmark Medtronic CoreValve US clinical trial begins
The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H Adams, and Samin K Sharma, at The Mount Sinai Medical Center in New York City.
Stem cell therapy demonstrates significant reperfusion in severe heart attack patients
The American Heart Journal reported on 21 December 2010 results of a clinical trial evaluating AMR-001 for the treatment of damaged heart muscle following acute myocardial infarction.
St Jude Medical launches new Trifecta valve in Canada
Next-generation pericardial tissue valve provides physicians with an advanced valve, designed for superior hemodynamic performance.
Nano-measurement of troponin levels proves an accurate predictor of deterioration in heart failure
Simple blood tests with new high sensitive assay show that even small changes accurately forecast 90-day prognosis.
Stentys begins large-scale study with its self-apposing stent for treatment of heart attacks
The APPOSITION III study will allow physicians to use the Stentys self-apposing stent in a real-life setting for the treatment of acute myocardial infarction patients.
Medtronic CoreValve system gains CE mark for new subclavian approach to TAVI
Approval is expected to expand access to care for patients with severe aortic stenosis whose femoral arteries are too narrow or are compromised due to disease.
Sheathless transradial intervention highly successful in treating complex lesions
Novel approach to angioplasty uses standard guiding catheters; promotes widespread adoption of transradial approach in the USA.
FDA approves study with Impella 2.5 to reduce heart muscle damage following PCI in STEMI patients
Abiomed has received conditional approval from the FDA to begin MINI-AMI, a randomised trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with STEMI.
Tryton announces investigational device exemption conditional approval from FDA to conduct US pivotal study of side branch stent
Martin B Leon, professor of Medicine, founder and chairman emeritus of the Cardiovascular Research Foundation, will serve as principal investigator of the study.
European Commission approves ticagrelor tablets
Brilique (AstraZeneca) has been authorised for the prevention of atherothrombotic events in adult patients with acute coronary syndromes.
Transcatheter mitral interventions: MitraClip and beyond
"We will witness the introduction of new devices to enrich the treatment portfolio, the development of image guidance to plan and execute the procedures, and the evolution of new clinical trends and, potentially, updated guidelines," Franscesco Maisano, Milan, Italy, writes to Cardiovascular News.
Eplerenone reduces risk of mortality in chronic heart failure patients with mild symptoms
Results of the EMPHASIS-HF study have shown that rates of heart failure hospitalisation, all-cause hospitalisation and all-cause mortality were also significantly reduced.
NICE guidance supports coronary drug-eluting balloon for in-stent restenosis
The SeQuent Please device should be considered for patients with in-stent restenosis and in cases where there are clinical reasons to minimise how long anticoagulant therapy is used.
TAVI should be new standard of care for “inoperable” patients
The surprisingly good results from the inoperable PARTNER cohort provides confidence that additional TAVI studies are justified in lower risk aortic stenosis patients and in other selected patient cohorts, Martin Leon said.
Boston Scientific to acquire Sadra Medical
Innovative percutaneous aortic valve replacement system provides entry into emerging market of structural heart disease.
Medtronic announces global launch of new heart valve repair ring
Tricuspid Annuloplasty ring is designed to adapt to the heart's natural tricuspid valve
Blue Medical receives CE mark approval for drug-eluting balloon and stent on drug eluting-balloon combination device
Blue Medical will introduce the CoCr stent on DEB, called Pioneer and its DEB, called Protege across Europe by the end of the year.
Carmat announces agreement with Edwards Lifesciences to use the Carpentier-Edwards Biological Heart Valves in Artificial Heart
Carpentier-Edwards biological heart valves were developed by Carmat co-founder and CSO Alain Carpentier and will be, for the very first time, used in an artificial heart.
Better preventative care could reduce coronary deaths in Europe
Data from the EURIKA study highlight the importance of identifying and managing patients with uncontrolled cardiovascular risk factors early.
George Dangas
George Dangas, co-director of Transcatheter Cardiovascular Therapeutics (TCT) conference, spoke to Cardiovascular News about his career, research and challenges facing interventional cardiology today.
Medtronic receives FDA approval for the Integrity coronary stent
Medtronic has received FDA approval for the Integrity coronary stent system. The device has been shown in bench testing and in blinded in vivo physician assessment studies to be highly deliverable.
Combination of paclitaxel-coated balloon and EPC stent shows significantly lower late loss
Results of the randomised, multicentre PERFECT STENT study were presented by Jochen Wohrle, Ulm, Germany, at the TCT conference.
Studies presented at TCT favour everolimus-eluting stents
SPIRIT IV and SORT OUT IV trials compared everolimus-eluting stents to paclitaxel- and sirolimus-eluting devices in large groups of patients.
All-cause mortality lower in patients treated with TAVI at one year
Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery, Martin Leon told delegates at the TCT conference.
Bioresorbable stent continues to show promising data
Positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial were presented at the 22nd annual TCT conference in Washington, DC.
PROMUS element stent approved for use in diabetic and heart attack patients in CE mark countries
PROMUS CE mark approval is well received by physicians.
Edwards lifesciences launches Magna Mitral Ease Valve
Magna Mitral Ease valve designed to enhance implantation in the challenging mitral position.
Medtronic gains CE mark for enhanced CoreValve delivery catheter system with AccuTrak stability layer
Technology advances allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValve device.
Phase II study showed switching ACS-PCI patients to Effient from Plavix regimen reduced maximum platelet aggregation after one week
The effects on the level of platelet aggregation achieved after switching from Plavix 75 mg once daily maintenance dosing plus aspirin to Effient 10 mg once daily maintenance dosing in patients with acute coronary syndrome.
Transfemoral or transapical aortic valve implantation?
On the first day of the 24th EACTS meeting, in Geneva, Cardiovascular News interviewed Michael Mack and Thomas Walter on TAVI trends in Europe and the USA.
Long-term data further supports the benefit of Cypher compared to the Endeavor in high-risk subgroups
Additional analysis of 18 month data of the SORT OUT III trial provides detail on safety and efficacy outcomes in patients with diabetes, acute coronary syndrome, or treatment of multiple lesions.
InfraReDx receives FDA clearance for LipiScan IVUS coronary imaging system
InfraReDx, Inc has announced clearance from the US FDA to market LipiScan IVUS, thus being the first catheter to combine near-infrared spectroscopy with intravascular ultrasound a valuable new tool to characterise coronary plaque and improve coronary stenting.
Cortisol levels in hair linked to heart attack risk
Cortisol levels in hair may be the first biomarker to measure chronic stress, which is linked to a higher risk of having a heart attack.
HeartWare receives second patient allotment under continued access protocol for pivotal US bridge-to-transplant clinical trial
The FDA has approved an Investigational device exemption supplement that allows HeartWare to enroll a second allotment of 54 patients in its ADVANCE bridge-to-transplant clinical trial, which is designed to evaluate the HeartWare® Ventricular Assist System for patients with end-stage heart failure.
Highlight from ESC 2010: A SHIFT in heart failure treatment
Large-scale study shows positive results for drug ivabradine in reducing chronic heart failure; EINSTEIN-DVT also shows positive outcomes for rivaroxaban.
Medtronic launches the Resolute Integrity Stent System
"Superior deliverability" distinguishes new medical drug-eluting stent for coronary artery disease from rivals, according to the company.
CORDIS announces results of ten-year CYPHER sirolimus-eluting coronary stent follow-up
Publication of decade follow-up test results on first CYPHER sirolimus-eluting coronary stent patient reveal the stent's outstanding efficacy and safety.
New NICE guidance published to improve diagnosis and treatment of chronic heart failure
Update on chronic heart failure replaces July 2003 clinical guideline.
Health care system delay may increase risk of death for heart patients receiving reperfusion therapy
Conclusion comes as the result of an unprecedented study into the association between system delay and outcome in patients with STEMI treated with primary PCI.
Mount Sinai researchers pioneer new method for detecting high-risk cardiovascular disease
School of Medicine becomes first institution in the world to use multi-colour CT technology in a pre-clinical setting.
All Comers trial shows Resolute as good as Xience V at one year
Target Lesion Failure rates marginally lower for Resolute, according to journal.
First ever patient given Biotronik DREAMS in Biosolve I Clinical Study
Clinical evaluation of a revolutionary new device technology for the treatment of vascular disease has begun.
FDA Advisory Committee recommends US approval of brilinta (ticagrelor) for ACS patients
Committee voted 7 to 1 in favour of Astrazeneca drug which outperforms rival plavix according to PLATO study.
Boston Scientific begins clinical trial enrolment for new coronary stent with bioabsorbable polymer and everolimus drug coating
Evolve trial to evaluate company’s fourth-generation Synergy drug-eluting coronary stent.
Bayer’s Rivaroxaban meets primary endpoint in long-term Phase III Einstein-DVT study
Rivaroxaban shows superiority to standard therapy in net clinical benefit; full data set to be presented at ESC 2010 Hot Line Session.
13-strong surgical team in training to implant new total artificial heart
Methodist to be first Texan hospital to offer FDA-Approved total heart replacement for transplant patients.
No firm conclusions about HDL cholesterol can be drawn from JUPITER sub-analysis
Lancet study may send out the wrong signals about cholesterol levels, ESC warns.
MAQUET Cardiovascular launches advanced VASOVIEW technology for Endoscopic Vessel Harvesting procedures in cardiac surgery
New device optimises harvesting technique to improve graft quality for coronary artery bypass graft patients.
Josep Brugada
Josep Brugada speaks to Cardiovascular News about his career, his proudest moments and his association with Barcelona FC.
Platinum Chromium Taxus Element stent system is launched in Europe
The Taxus Element Stent System is the company's third-generation drug-eluting stent (DES) technology; it received CE mark approval in May.
Europe on the front line of transcatheter aortic valve advancement
"Europe has continued to be the stage upon which major developments with this technology have debuted," Dr Martyn Thomas claims.
Alternatives to today’s drug-eluting stents
Dr David Smith advocates a shift away from stents that involve the need for dual-antiplatelet therapy.
Diabetic patients benefit from the Genous Bio-engineered R stent
Twelve-month data shows the OrbusNeich Genous Bio-engineered R stent to be effective in diabetic patients.
Bioresorbable stent one step closer to becoming a reality
Six-month data shows positive results for revolutionary BVS technology.
“Encouraging” TAVI results in high-risk patients
Results suggest transcatheter valve implantation is best treatment choice for patients undergoing non-conventional surgery.
Caduet reduces 10-year calculated risk of coronary heart disease, fatal cardiovascular disease
Data presented at 20th ESH meeting shows a relative risk reduction of nearly a third after 12 months of treatment.
Genfit announces its development plan for GFT505
Company plans to advance development of the drug following results presented at the American Diabetes Association's 70th Scientific Sessions.
For heart failure patients, risk of in-hospital death has decreased; readmission rate has increased
Authors' report published in JAMA June 2010 issue suggests patient outcomes "have not improved in all areas".
Rosiglitazone associated with increased cardiovascular risks and death
New JAMA study strengthens argument against the medication's use on type 2 diabetes patients.
New expert guidelines allow more patients with pre-existing heart conditions to travel by air
New national report defeats the myth that airline passengers with heart conditions pose a safety risk.
Rcadia COR Analyser System demonstrates potential for CAD triage in low risk patients
Five studies presented at Society of Cardiovascular Computed Tomography Annual Scientific Meeting held in Las Vegas.
REDUCE Clinical Study on target to impress, claims Gore
Gore reaffirms commitment to multinational, randomised study on PFO closure in stroke.
St Jude Medical completes acquisition of LightLab Imaging
Acquisition makes St Jude Medical the first company to offer both optical coherence tomography and Fractional Flow Reserve technology.
Optical coherence tomography to detect incomplete tissue coverage of metallic stent struts
Francesco Prati discusses how drug-eluting stents have been found to dramatically reduce the incidence of restenosis.
Less strict heart rate control is effective
A study presented at ACC 2010 has shown that lighter control of heart rate can be as effective as strict control
Ostial left anterior descending arteria stenosis treated by percutaneous coronary intervention and Promus Element everolimus-eluting stent system
Hannu Romppanen and Matti Niemelä discuss the use of the Promus Element everolimus-eluting stent system
World’s First Prohealing Stent Featured in Live Case Demo at AICT
OrbusNeich lead the way in stent research with AICT showcase.
St Jude Medical announces initiation of a study to evaluate the economic impact of FFR in Europe and Canada
The analysis will evaluate the cost effectiveness of an FFR-guided intervention strategy for patients with multivessel coronary artery disease in eight countries.
Data presented at EuroPCR demonstrate effectiveness of the Genous Bio-engineered R stent in diabetic patients
Peter Damman, Academic Medical Center, Amsterdam, The Netherlands, presented the subset analysis from 1,236 diabetic patients at EuroPCR.
Edwards Sapien Transcatheter Heart Valve shows positive one-year outcomes in post-market study
Martyn Thomas reported at EuroPCR that the device demonstrated promising one-year mortality rates for high-risk patients, many of whom were too sick to undergo open-heart surgery.
Medtronic CoreValve System shows long-term efficacy and durability in pivotal trial
Transcatheter aortic valve delivers positive clinical outcomes through two years in major international study and achieves 10,000-patient milestone.
New data on Abbott’s Bioresorbable Vascular Scaffold reinforces its potential to be the next revolution in interventional cardiology
Positive six-month results from the first 45 patients enrolled in the second stage of the ABSORB trial were presented at the EuroPCR meeting in Paris.
Medtronic’s Resolute drug-eluting stent matches market-leading rival in large head-to-head study
One-year clinical results from innovative RESOLUTE All Comers Trial show excellent performance for Resolute DES in challenging patient population.
Tryton announces positive data from side branch system at EuroPCR
Robert-Jan Van Geuns and Maciej Lesiak presented studies showing that the Tryton Stent demonstrated procedural rates of 94% and 98.5% respectively.
Boston Scientific begins PLATINUM PLUS Trial for Promus Element Stent System
Randomised study of nearly 3,000 patients will evaluate Company's third-generation drug-eluting stent technology.
Nevo sirolimus-eluting coronary stent continues to demonstrate excellent safety and efficacy outcomes in new 12-month data
Nevo, incorporating RES Technology, continues to support excellent safety and efficacy outcomes vs. the Taxus Liberté according to data presented at EuroPCR 2010.
Boston Scientific announces CE mark and FDA approval of NC Quantum Apex Balloon Catheter
The Company plans to launch the product in European markets this week and in the US next month.
Pantera Lux Paclitaxel Releasing Balloon is launched during the EuroPCR meeting
Biotronik's first drug eluting balloon is indicated for the treatment of coronary in-stent restenosis.
MitraClip demonstrates strong safety results and improved clinical outcomes for common causes of leaky heart valves
Preliminary results also show MitraClip device maintains durability through two years in patients treated for mitral regurgitation.
New data reinforces safety profile of Xience V
In the XIENCE V USA study, the device demonstrated low blood clot rate at one year; in SPIRIT V Diabetes Trial, Xience V had zero cases of stent thrombosis at one year.
Tryton side-branch stent launched in Europe
A new side-branch stent for the treatment of bifurcation lesions has been launched by Tryton Medical. The Tryton Side Branch Stent System is now available in Austria, Belgium, Denmark, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. Bifurcation lesions are the largest unmet need confronting interventional cardiology.
Physio-Control launches new version of Lifenet
A new version of a web"based platform designed to share emergent patient information between Emergency Medical Services (EMS) and hospital care teams has been launched.
Audio: Interview with Prof Didier Carrié
Prof D. Carrié speaks to Cardiovascular News about progress in percutaneous coronary intervention.
No ACCORDance on role of fibrates
Results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showed that a combination of fenofibrate and simvastatin failed to reduce risk of fatal cardiovascular events compared to simvastatin alone.
Percutaneous device climbs to new heights in valvular therapy
A new device designed to combat mitral regurgitation (MR) met primary safety and efficacy endpoints in the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II, it was reported during a late-breaking data session at the American College of Cardiology 2010 scientific sessions in Atlanta, USA on 14 March.
Cypher vs. Endeavor trial results cause a stir
Results from the SORT OUT III trial presented at ACC 2010 surprised delegates by showing that the Cypher stent was associated with significantly lower rates of major adverse cardiac events (MACE), all-cause mortality, myocardial infarction (MI) and target lesion revascularisation (TLR).
Data at JIM show bio-engineered stent may be good choice for patients not suitable for antiplatelet therapy
Clinical data presented at the Joint Interventional Meeting (JIM) 2010 in Rome provide further evidence that Orbus Neich's Genous stent could be a treatment of choice for patients not suitable for long-term dual antiplatelet therapy.
FDA approves HeartMate II for destination therapy
The US Food and Drug Administration has approved Thoratec's PMA (pre-market approval) supplement, allowing the use of its HeartMate II left ventricular assist system for destination therapy.
Alfredo R Galassi
Alfredo R Galassi, director of diagnostic and cardiovascular interventional laboratory, Ferrarotto Hospital University of Catania, Italy, and associate professor of cardiology, University of Catania, Italy, tells Cardiovascular News International about his career journey to date, and his love of sailing
Resolute maintains sustained efficacy and safety in long-term follow-up
Three-year results of the RESOLUTE trial include no new target lesion revascularisations and no instances of stent thrombosis.
Transcatheter heart valve replacement: A European perspective
Since the first percutaneous implantation of a pulmonary valve in a human was reported for the first time in 2000, transcatheter heart valve procedures have recorded constant double-digit growth year-on-year, offering a new option to candidates not suitable for conventional surgery.
Progress in transcatheter heart valve techniques
Alain Cribier, who performed the first double balloon technique for dilatation of valvular stenosis in 1985, spoke to Cardiovascular News International about the evolution of percutaneous techniques.
Abbott’s Xience V approved in Japan
The everolimus-eluting stent, Xience V has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW), Abbott has announced.
NICE recommends prasugrel plus aspirin for acute coronary syndromes
New guidance recommending the use of prasugrel in combination with aspirin as an option for preventing blood clots in the arteries of people with acute coronary syndromes has been published by the National Institute for Health and Clinical Excellence (NICE).
Controversy surrounds long-term lipid lowering therapy
The results of the ARBITER 6-HALTS trial raised questions and prompted heated
discussion at the American Heart Association scientific sessions.
Patients at limited compliance or non-responsiveness to double antiplatelet therapy
Carlo Briguori, Naples, Italy, discusses the difficulties in compliance and low response to dual antiplatelet therapy.
Latest techniques showcased in Leipzig
The latest progress in traditional heart surgery, minimally invasive and transcatheter techniques were presented in a two-day congress at the Heart Centre, University of Leipzig, Germany.
First patient enrolled in REMEDEE Combo Stent trial
OrbusNeich have announced the initiation of patient enrolment in the randomised clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent).
First transcatheter valve cases in Japan performed with Edwards Sapien valve
The transfemoral and transapical valve implantations were performed by Osaka University in preparation for application submission to the Japanese Ministry of Health, Labour and Welfare.
Xience Prime and Xience V receive CE mark for treatment of diabetic patients
Expanded indications for Abbott's coronary stents are based on data from the SPIRIT family of randomised trials.
Edwards Lifesciences’ newest aortic valve demonstrates no patient-prosthesis mismatch
Results for the Carpentier-Edwards Perimount Magna Ease valve were presented at the European Association for Cardio-Thoracic Surgery annual meeting, in Vienna, Austria.
Two-year HORIZONS-AMI data continue to show superior efficacy for Taxus Express and bivalirudin in heart attack patients
Two-year follow-up data from the HORIZONS-AMI trial presented at the TCT conference show that Taxus and bivalirudin maintained their advantage in ST segment elevation myocardial infarction patients that was shown at one year.
Trials show positive results for Xience V
Abbott Vascular’s Xience V stent has been shown to be superior to other drug-eluting devices in two trials reported at the Transcatheter Cardiovascular Therapeutics 2009 annual meeting in San Francisco, California, USA.
Intravascular ultrasound can predict events, PROSPECT shows
The results of the PROSPECT trial show that the identification of lesions can be enhanced by intravascular ultrasound.
MitraClip EVEREST registry results positive at TCT
Percutaneous heart valves get a boost as Abbott acquires Evalve.
LEADERS two-year data: Biodegradable polymer technology is safe and effective
Two-year results of the LEADERS trial show an increasing trend towards a safety benefit for the biolimus A9-eluting stent with abluminal biodegradable polymer
LEADERS two-year data: Biodegradable polymer technology is safe and effective
Two-year results of the LEADERS trial show an increasing trend towards a safety benefit for the biolimus A9-eluting stent with abluminal biodegradable polymer.
Symplicity Catheter System demonstrates durable blood pressure reduction in hypertension patients
Data supporting the long-term safety and effectiveness of renal sympathetic denervation in treating patients with chronic hypertension were presented at the TCT conference.
US surgeon performs first beating heart fully endoscopic bypass surgery using miniaturised Maquet’s cardiopulmonary bypass system
Minimised ExtraCorporeal Circulation (MECC) system offers new approach to improve patient safety during heart surgery.
Combo Stent may offer advantages to current drug-eluting stent technologies
Pre-clinical data were presented at the TCT conference. OrbusNeich set to initiate patient enrolment in human clinical trial in fourth quarter.
FAME demonstrates continued reduction in risk of death or heart attack with fractional flow reserve technology at two years
Trial shows an FFR-guided strategy to treat multivessel coronary artery disease both improves outcomes and is cost-saving compared to procedures using angiography alone
Maquet receives FDA clearance for Mega, the world’s first 8F 50cc intra-aortic balloon catheter
Mega has a smaller insertion point than traditional 50cc intra-aortic balloons and offers additional blood volume displacement for intra-aortic balloon counterpulsation.
MitraClip shows sustained results in studies presented at TCT
Data on histopathology, mechanical integrity of the device, left ventricular reverse remodeling, and mitral valve annulus dimensions were released in San Francisco.
Taxus Liberte demonstrates improvements over Taxus Express in small vessels and long lesions
Three-year Taxus ATLAS results show safety and efficacy advantages for Boston Scientific Taxus Liberte Stent.
Endeavor reduced risk of heart attack and cardiac death by 48% at three years compared to Taxus
Latest findings from ENDEAVOR IV clinical trial also showed 91% reduction in risk of very late stent-related blood clots for Endeavor patients.
Blood flow blockages in the heart can be measured using wireless fractional flow reserve technology
New diagnostic tool combines St Jude Medical's PressureWire Aeris with GE's Mac-Lab Hemodynamic Recording System.
Resolute maintains sustained efficacy and safety in long-term follow-up
Three-year results of the Medtronic's RESOLUTE trial include no new target lesion revascularisations and no instances of stent thrombosis.
Guided Delivery Systems successfully treats first patient with mitral regurgitation
Implantation of the GDS Accucinch System significantly reduced the patient's mitral regurgitation without requiring open heart surgery.
Novartis receives FDA approval for Valturna to treat high blood pressure
Valturna combines in a single pill valsartan, an angiotensin receptor blocker, with aliskiren, the only approved direct renin inhibitor.
Boston Scientific completes enrolment in pivotal trial for the Promus Element stent
PLATINUM clinical programme will support US and Japanese approval of new everolimus-eluting coronary stent system.
Boston Scientific announces release of next-generation iLab system software
Boston Scientific announced on 21 September 2009 release of its CE-marked, next-generation iLab System Software for the iLab Ultrasound Imaging System.
Genous Bio-engineered R stent is feasible
OrbusNeich's Genous Bio-engineered R stent is feasible and safe in patients who need coronary revascularisation before undeferrable non-cardiac surgery and have to discontinue dual antiplatelet therapy.
Abbott announces Xience V approval in China
Company plans fourth-quarter launch for XIENCE V in China, the second-largest drug-eluting stent market in the Asia-Pacific region.
KYOTO HEART shows benefits of valsartan
The addition of the angiotensin receptor blocker (ARB) Diovan to a non-ARB-based treatment regimen for high blood pressure provided a 45% relative risk reduction in cardiovascular events.
Abbott to acquire Evalve, a leader in mitral valve repair technology
Acquisition expands vascular portfolio and provides Abbott with global leadership position in non-surgical treatment option for mitral valve repair.
First human cases performed with Edwards Lifesciences’ new transapical heart valve system
The procedures with the new lower-profile Ascendra 2 transapical delivery system were conducted at the University of Leipzig Heart Centre, Germany.
CID announces CE mark of its new Avantgarde cobalt chrome Carbostent
According to the company, Avantgarde represents the latest and most advanced drug-free technology for the treatment of cardiovascular disease.
New drugs steal the spotlight at the ESC Congress 2009
Results of the PLATO, RE-LY, PRAGUE-7, and PROTECT trials were presented during the conference in Barcelona, Spain.
Secondary prevention of cardiovascular disease in Europe: Prescribing pills is not sufficient
Kornelia Kotseva, Imperial College, London, UK, analyses the results of the EUROASPIRE surveys.
(Drug-eluting?) Coronary stenting in patients on chronic oral anticoagulation
Andre Rubboli, Bologna, Italy, analyses a polymer-free, Carbofilm coated stent eluting tacrolimus from abluminal reservoirs, which has been widely tested in patients with either stable or unstable coronary artery disease.
Women slightly more likely to die in the 30 days following a heart attack
Study found that women may have a slightly higher risk following an acute coronary syndrome, but that these differences appear to be attributable to severity and type of syndrome.
Drug-eluting stents are warranted for infarction
TYPHOON and STRATEGY, two trials with long-term follow-up periods, showed sustained benefits for the Cypher stent when compared to bare metal stents.
Death rate decreases following hospitalisation for heart attack
Study showed that, from 1995-2006, hospital 30-day death rates decreased significantly for Medicare patients hospitalised for a heart attack.
Genetic variation associated with outcomes with use of clopidogrel
Patients with a certain genetic variation who received clopidogrel had a decreased platelet response to treatment according to a new study.
Health Canada approves Abbott’s Xience V
The clinical program for Xience V studied patients in the US, Canada, Europe, South Africa and Asia-Pacific, and demonstrated excellent long-term results.
Heart disease risk may come from little known type of cholesterol
Chinese scientists presented one of the first studies suggesting that oxycholesterol may be the most serious cardiovascular health threat of all.
Syntax Score website: A tool for the best strategy
A website dedicated to the use of the Syntax Score, a novel angiographic tool used to measure the complexity of coronary artery disease, was launched at EuroPCR.
Nevo yields superior results to Taxus in pivotal clinical trial
In the randomised NEVO RES-I trial, the Nevo sirolimus-eluting stent had significantly lower in-stent late lumen loss than the Taxus-Liberté device.
FDA approves Boston Scientific’s Taxus Liberte Long Stent
At 38mm, it is the longest available drug-eluting stent and affords a more efficient treatment option for the estimated 8-10% of patients with long lesions.
Silvia Priori
Silvia G Priori spoke to Cardiovascular News about her career, research, joy in spending time with her two children, and the occasion she took beta-blockers before meeting Dr Mike Rosen.
Children: A forgotten population
Jamie S Sutherell, cardiology fellow at Cincinnati’s Children Hospital, US, analysis the lack of paediatric medical devices and off-label use.
ASH: Darusentan helpful in resistant hypertension
The systolic blood pressure goal of ?140mmHg was met by half of patients receiving the drug, according to a study presented at the American Society of Hypertension meeting.
Effient is approved by the FDA
Daiichi Sankyo and Lilly' Effient reduces thrombotic cardiovascular events in patients with acute coronary syndromes managed with percutaneous coronary intervention.
Long-term recovery for DES is confirmed
The number of PTCAs performed between January and March in Western Europe was 0.3% higher than in the Q4 2008 and 1.2% lower than in Q1 2008. The DES penetration rate was measured at 51.9%.
Tryton announces first patient enrolment in E-Tryton 150 Registry
Study will assess Tryton side-branch stent in real-world settings. The device demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients.
FDA approves dronedarone for patients with atrial fibrillation or atrial flutter
Approved to reduce the risk of cardiovascular hospitalization, Multaq will be launched this summer in the US by Sanofi-aventis.
Six month clinical outcomes of supralimus-sirolimus-eluting stent presented at EuroPCR
The dataset demonstrated excellent results in high-risk patients with complex coronary lesions, including high procedural success rate and sustained safety.
New communication technologies help cardiac patients improve their prognosis
Study shows that phone and Internet-based interventions make rehabilitation programmes more accessible after a heart attack.
Replagal shows significant benefits in women with Fabry disease
Results from the largest and longest examination of enzyme replacement therapy in female demonstrated benefits on kidney function, heart function and burden of disease.
Abbott enrolls first patient into SPIRIT PRIME trial in the US
Investigation will study the performance of the Xience Prime everolimus-eluting stent, currently an investigational device, for the treatment of coronary artery disease.
Pitavastatin demonstrates promise for low incidence of drug-drug interaction
Study presented at the XV International Symposium on Atherosclerosis shows novel synthetic statin is safe and well tolerated in combination with warfarin.
Combination therapy helped more patients reach combined targets for key lipid targets
Trilipix delayed-release capsules in combination with rosuvastatin calcium achieved individual and combined lipid targets in patients with mixed dyslipidemia and type 2 diabetes.
BARI 2D trial presented at the American Diabetes Association annual meeting
The Society for Cardiovascular Angiography and Interventions encourages healthcare providers to apply the findings of BARI-2D, when appropriate, to their patients, as studied in this trial.
Promising safety and efficacy results for Relaxin
Analyses conducted from Pre-RELAX-AHF study showed that drug for acute heart failure treatment was the strongest independent predictor of improved longer-term outcomes.
FDA approves next-generation Taxus Liberte Atom Stent System
Boston Scientific has received approval to market its new drug-eluting stent specifically designed for treating small coronary vessels.
SCAAR registry provides reassurance on drug-eluting stent safety
Study analyses the outcomes of 47,967 patients entered into the Swedish Coronary Angiography and Angioplasty Registry between 2003 and 2006.
BI-204 shows positive results for prevention of events associated with atherosclerosis
BioInvent International AB has announced that its therapeutic antibody product candidate has reached the primary endpoint in its phase I trial, and was safe and well tolerated.
What is the future of cardiovascular surgery?
How much work cardiologists will take away from surgeons was one of the topics debated at the ESCVS meeting held in Warsaw, Poland, from 30 April–2 May.
Mild heart failure: The REVERSE findings
Dr Dirk J van Veldhuisen analyses the findings on the use of CRT for heart failure patients classes I and II and how the results will impact in future studies.
New analysis evaluated impact of genetic variation on response to prasugrel
Substudy from the TRITON-TIMI 38 trial showed that patients who took prasugrel and had a reduced function of the CYP2C19 gene did not have an increased risk of cardiovascular events.
One in 1,000 risk of death from catheter ablation for atrial fibrillation
Analysis of data from 162 centres worldwide between 1995 and 2006 showed that tamponade caused the highest number of fatalities, followed by stroke and atrioesophageal fistula.
Ethnicity affects timing and access to cardiac care
Research led by University of Calgary, Canada, shows ethnic variation in heart disease symptoms.
New enhancements to the Philips HeartStart MRx support fast triage of STEMI patients
Innovations in decision support, quality CPR and information management solutions help reduce critical time to lifesaving treatment.
Chemical found in medical devices impairs heart function
Study showed that material commonly used in the production of such medical plastic devices as intravenous bags and catheters can impair heart function in rats.
CID announces successful defence of European patent against an opposition filed by Conor Medsystem
CID has announced that it has successfully defended European Patent 1277449 against an opposition filed by Conor Medsystem on proprietary drug-eluting stent technology.
Statin therapy “highly effective and safe” in cardiac and noncardiac patients
Dr Maciej Banach, Medical University of Lodz, Poland, presented at The European Society of Cardiovascular Surgery meeting a range of studies showing the benefits of statin.
Better outcomes with bypass surgery for multivessel disease
Results of a Chinese study showed that patients receiving drug-eluting stents had considerably higher three-year rates of target vessel revascularisation.
New target for maintaining healthy blood pressure discovered
Study found that mice that lack the receptor for one type of the fatty compound prostaglandin have lower blood pressure and less atherosclerosis than their nonmutant brethren.
Novel system for diagnosis of stenosis allows prioritisation of critical cases
Software designed for the interpretation of coronary CT angiography helps radiologists determine which cases are high priority and should be read first.
Genous demonstrates “impressive” results in high-risk patients
OrbusNeich bio-engineered R stent showed low rate of stent thrombosis in studies presented at the Angioplasty Summit TCT Asia Pacific 2009.
Fatty fish and marine omega-3 may reduce risk of heart failure
Eating fatty fish and marine omega-3 fatty acids, which are found in fish oil, seems to protect men, according to one of the largest studies to investigate the association.
Professor Christian Hamm
Cardiovascular News talks to Professor Christian Hamm, Bad Nauheim, Germany, about his influences, current areas of research, and the challenges facing cardiology.
St Jude Medical’s implantable cardioverter defibrillators receive CE mark
AnalyST Accel and Current Accel provide new alerts and insight into cardiac conditions such as atrial fibrillation and ischaemia.
Opinion: “Why we prefer the minicrush as a two-stent strategy”
Professor Alfredo Galassi, Catania, Italy, analyses the techniques for the treatment of bifurcation lesions.
ACC: Statins take centre stage again
The benefits of rosuvastatin extend to preventing venous thromboembolism, according to analysis of the JUPITER study.
Five-in-one polypill may halve risk of cardiovascular disease
Healthy individuals may be able to cut their risk of cardiovascular disease by 50 to 60% by taking a single pill that combines three blood pressure lowering drugs, a statin, and aspirin.
BIBA Research’s fourth quarter 2008 report confirms recovery of drug-eluting stent use
The penetration rate was measured at 51.6% in Western Europe: this represents the fifth consecutive increase since the third quarter 2007.
New tool calculates risk of bleeding in heart attack patients
Using clinical variables, American researchers created a method to estimate bleeding risk and help lessen the chances that heart attack patients will experience this complication.
Study suggests black tea may help maintain cardiovascular function
Tea consumption simultaneously increased blood vessel reactivity and reduced both blood pressure and arterial stiffness.
Maquet Cardiohelp wins design awards
The Design Zentrum Nordrhein-Westfalen has bestowed the red dot design award on the world's smallest cardiopulmonary support system Cardiohelp.
Screening diabetics for coronary disease does not reduce risk of cardiac events
Study shows screening did not result in a significant reduction in the rate of heart attacks or cardiac death compared to patients who were not screened.
UK has its first percutaneous mitral valve repair patients
The treatment of mitral regurgitation using the MitraClip system has demonstrated success in the first UK patients who have undergone the procedure.
Exercise may provide benefit for heart failure patients
Aerobic exercise training appears safe for patients with heart failure and was associated with a modest reduction in the risk of death and hospitalisation.
Two nondrug treatments appear to reduce depression after heart surgery
Cognitive behavior therapy and supportive stress management appear more effective than usual care for treating depression after coronary artery bypass surgery.
Tips & tricks on PCI for chronic total occlusions
Dr Alfredo Galassi, Italy, launches practical handbook for interventional cardiologists willing to improve skills in the field of revascularisation of CTO.
Opinion: From here to JUPITER
Dr Erica Spatz tells how a new analysis estimated the number of older American adults who may benefit from statin therapy following the JUPITER trial results.
New tests provide insight into why patients are in heart failure
Study showed that people in heart failure have less of the enzyme needed to activate a hormone that helps reduce extra sodium and fluid that tax the cardiovascular system.
Medtronic announces international market release of Driver Sprint RX
The new system combines the Driver bare metal stent, platform of the company's coronary stents, with an improved delivery system.
Heart failure guidelines focus on key research findings, clinical advances
The updated document includes an entirely new section on managing patients who are hospitalised with acute heart failure.
SYNTAX analysis favours PCI in many patients
A new report from the trial shows that the advantages of bypass surgery are less obvious once quality of life and economic data are included in the analysis.
Lower risk of death and heart attack with drug-eluting stents
Comparative effectiveness study of 262,700 American patients was presented at the American College of Cardiology's 58th Annual Scientific Session in Orlando, USA.
More from JUPITER: Reduced risk of thromboembolism in healthy patients
New analysis from the trial show that rosuvastatin significantly cut the risk of venous thromboembolism by 43% compared to placebo.
Surgery to reshape ventricle offers no added benefit over bypass graft
Study shows that the procedure not only failed to reduce deaths and hospitalisations in heart failure patients but also did not improve quality of life.
Exenatide clinical data analysis shows no increased risk of cardiovascular events
Large cardiovascular outcomes study to be initiated will evaluate the effects of the drug once weekly compared to standard of care with traditional antidiabetes medications.
Salt consumption should be reduced to 1,500mg a day
New data from the American Centers for Disease Control and Prevention provide additional evidence that limiting amount of sodium can prevent and reduce hypertension.
Boston Scientific’s rating outlook is raised
Standard and Poor’s has raised the company’s rating outlook to positive from negative, while affirming the company’s corporate credit rating at BB+.
Study shows finger device may help predict heart events
Noninvasive sensor test is "highly predictive" of heart attack or stroke for people who are considered at low or moderate risk.
Recently identified genetic heart disorder often deadly for young patients
Study found that progression of a rare type of cardiomyopathy linked to a genetic mutation may be rapid and often results in early death.
Infinitt North America to show new cardiology PACS solutions at ACC09
Company will launch a complete image management system that provides image management software and image acquisition, storage, display and web distribution devices.
Siemens highlights C-reactive protein test at ACC09
The hsCRP test used in the JUPITER trial will be available in the company's booth in the upcoming event in Orlando, USA.
