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FDA approval for Permaseal transapical access and closure device

Micro Interventional Devices has received FDA market clearance for its Permaseal transapical access and closure device—just seven weeks after the device was CE mark...

Oral abstract on DuraGraft to be presented at EACTS

Miguel Haime (VA Boston Healthcare System and Boston Medical Center, Boston, USA) is to present an abstract about Somhulation's DuraGraft during a rapid response session at the 2016 annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; 1–5 October, Barcelona, Spain).

The American Academy of Neurology says no to routine PFO closure...

In revised recommendations, the American Academy of Neurology (AAN) states that catheter-based closure should not be routinely recommended for people who have had a stroke and also have patent foramen ovale (PFO). The practice advisory, which updates a previous AAN guideline, has been published in Neurology.

US FDA releases draft guidance on real-world evidence and medical device...

According to an email from the consumer watchdog, the document is intended to clarify "how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make those decisions."

ClearFlow launches smaller PleuraFlow active clearance technology for paediatric use

After receiving clearance from the US Food & Drug Administration (FDA) earlier this year for expanded Indications for Use with the company's patented technology, ClearFlow has developed a new model of the PleuraFlow product for the paediatric market.

Providence Health Care adopts HeartFlow FFRct Analysis to assess coronary artery...

Providence Health Care has become the first centre in Canada to adopt the HeartFlow FFRct Analysis, and also first in the world to use the next generation version of the platform. The HeartFlow FFRct Analysis, which was recently approved by Health Canada, is a non-invasive technology used by clinicians to assess their patients for coronary artery disease.

New website for Xenios

Xenios AG, a developer of lung and heart assist therapies, has combined its novalung, i-cor, and medos websites into www.xenios-ag.com to further advance the Xenios platform. With the new Xenios website, the Heilbronn-based medical device company further advances its lung and heart assist therapy platform.

Study indicates signal for valve degeneration in TAVI patients by eight...

Speaking at EuroPCR (17–20 May, Paris, France), Danny Dvir reported that there is a significant increase in valve degeneration between five and seven years after a transcatheter aortic valve implantation (TAVI) device is implanted.

TAVI durability: A rose by any other name is still a...

The data that Dvir presented at EuroPCR, as reported by Cardiovascular News, indicate that there is a significant increase in valve degeneration between five and seven years after a transcatheter aortic valve implantation (TAVI) device is implanted.

First patient enrolled in left main study of Xposition S

Stentys has started to enrol patients in its TRUNC trial, which is designed to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main coronary artery disease.

Safety and efficacy of Carillon mitral contour system confirmed

According to a study published in Open Heart, treatment with the Carillon device (Cardiac Dimensions) significantly reduces annular dimensions and improved mitral regurgitation, heart failure symptoms, and functional capacity in patients with functional mitral regurgitation.

Robotic-assisted PCI is safe and feasible for complex procedures

Results from the CORA-PCI (Complex robotically assisted percutaneous coronary intervention) indicate that robotic-assisted percutaneous coronary intervention (PCI), using the CorPath system (Corindus Vascular Robotics), is a safe and feasible approach to managing patients with complex lesions.

Moderate risk of upper gastrointestinal bleeding after TAVI

A large cohort study, published in Catheterization and Cardiovascular Interventions, indicates that TAVI is associated with an overall 2% risk of upper gastrointestinal bleeding.

Manta large bore vascular closure device now approved in Europe

Essential Medical has received CE mark approval for Manta; its large bore vascular closure device. The device is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as TAVI.

AHA warn that some over-the-counter drugs may cause or worsen heart...

Commonly used medications and nutritional supplements may cause or worsen heart failure, according to the first scientific statement from the American Heart Association (AHA) to provide guidance on avoiding drug-drug or drug-condition interactions for people with heart failure.

Health Canada approves Abbott Absorb stent

Health Canada has approved Abbott's Absorb bioresorbable heart stent, making the device commercially available to treat people in Canada with coronary artery disease.

Enrolment completed in US early feasibility study on tricuspid repair

Mitralign has announced that enrolment in the first phrase of its SCOUT study, which is evaluating percutaneous tricuspid repair with the Trialign system in patients with functional tricuspid regurgitation, has been completed.

“Strikingly higher” survival rates with Sapien 3 at one year compared...

Overall one-year survival was over 85% for high-risk or inoperable patients who underwent transcatheter aortic valve implantation (TAVI) with Sapien 3, according to a study published in Circulation.

Heart failure after first myocardial infarction linked to cancer

A study published in the Journal of the American College of Cardiology (JACC) indicates that patients who develop heart failure after their first myocardial infarction have a greater risk of developing than those who do not develop heart failure after a first myocardial infarction.

Essential Medical to begin US clinical trial of its large bore...

Essential Medical has received IDE approval from the FDA to begin the US clinical trial of its large bore vascular closure device (Manta). The study will evaluate the safety and efficacy of vascular access closure using Manta for femoral arterial access site.

Sunshine Heart to focus on neuromodulation for heart failure

Sunshine Hearth has updated its clinical strategy, which it says could benefit an under-served population of patients with Class III heart failure and other related conditions. The company is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation.

First single monthly injection of a PCSK9 Inhibitor approved in the...

Amgen has received FDA approval for its Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420mg of Repatha in a single dose.

Exploring the borders of TAVI

The NOTION 2 trial, which recently enrolled a 64-year-old female with Society of Thoracic Surgeon (STS) score 1.2% as its first patient, is comparing the use of TAVI with the use of surgical aortic valve replacement in patients aged ≤75 years at low surgical risk.

Combined percutaneous treatment of aortic stenosis and mitral regurgitation is feasible

Martina Patané and colleagues found that percutaneous edge-to-edge repair (MitraClip, Abbott Vascular), either as a planned staged treatment or as a bailout therapy, is feasible and effective approach in mitral regurgitation patients who have undergone TAVI.

Cardiovascular Systems submits Diamondback 360 Coronary Orbital Atherectomy System Micro Crown...

Cardiovascular Systems Inc (CSI) has submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of its Diamondback 360 Coronary Orbital Atherectomy System Micro Crown to treat severely calcified coronary arteries for the facilitation of stent placement.

CE mark for QT Vascular’s Chocolate Heart drug-coated balloon

QT Vascular has received CE mark clearance for the sale and distribution of its Chocolate Heart drug-coated balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe.

CorPath to be featured at San Diego Cardiovascular Interventions Course

Corindus Vascular Robotics' CorPath system will be highlighted in several presentations on new therapies and techniques for the treatment of high-risk patients with complex cardiovascular disease at the San Diego Cardiovascular Interventions Course (SDCI; 8–9 July, San Diego, USA).

Study confirms safety of using Tryton stent to treat coronary bifurcation...

The Tryton Confirmatory Study, recently published in JACC Cardiovascular Interventions, has confirmed the safety and efficacy of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5mm stent).

Versa Capital Management to acquire SynCardia Systems

SynCardia Systems has entered into an asset purchase agreement with an affiliate of Versa Capital Management to acquire substantially all of the company's assets and operations, bringing with it the ability to provide the capital necessary for SynCardia to realise its full potential as the world's first and only FDA, provider of the Total Artificial Heart and drivers.

High prevalence of delirium found in cardiac arrest patients with therapeutic...

A study published in the American Journal of Critical Care has found a high prevalence of delirium in a small cohort of critically ill patients treated with therapeutic hypothermia after cardiac arrest.

First patient treated in NOTION-2 trial of TAVI in younger patients

A 64-year old female with severe aortic stenosis and low surgical risk (STS score 1.2%) has been treated at Rigshospitalet in Copenhagen, Denmark, with transcatheter aortic valve implantation (TAVI), becoming the first patient in the NOTION-2 trial.

Industry-sponsored meals linked to increased rate of prescribing brand-name drugs

A study, published in the JAMA: Internal Medicine, indicates that doctors who receive industry-sponsored meals have higher rates of brand-name drug prescriptions than alternative options within the same drug class.

FDA clears QT Vascular Chocolate XD balloon

QT Vascular, together with its subsidiaries, has receivedFDA 510(k) clearance for the Chocolate XD percutaneous transluminal coronary angioplasty catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

Twisting of the heart may predict mitral valve surgery outcomes

A simple preoperative echocardiographic measurement of the amount of torsion of the heart predicted outcomes of mitral valve surgery in some heart failure patients, according to a novel study published in JACC: Basic to Translational Science.

Bioventrix receives CE marking for Revivent TC system

BioVentrix has received certification for CE marking its Revivent TC transcatheter ventricular enhancement system.

RenalGuard features in high-risk live case at CTO Fundamentals Course

RenalGuard Solutions has been featured in a high-risk coronary chronic total occlusion (CTO) live case presentation at the recent CTO Fundamentals Course, June 3, 2016, VU University Medical Center, Amsterdam, The Netherlands.

Prior radiation therapy is associated with increased risk of mortality in...

Grant W Reed, Milind T Desai and others report that prior external beam radiation therapy is an independent predictor of both all-cause and cardiovascular mortality in patients undergoing PCI.

Trials on newer generation drug-eluting stents in small coronary vessels needed

A network meta-analysis of early generation, drug-eluting stents, bare metal stents, drug-coated balloons, and balloon angioplasty indicate that sirolimus-eluting stents are associated with the most favourable angiographic and clinical outcomes for lesions in small coronary arteries.

Next-generation of HeartFlow launched

HeartFlow has announced that it has launched its next generation of its HeartFlow FFRct system. The result of years of development, the next-generation platform includes major advancements in the process and algorithms HeartFlow uses to calculate fractional flow reserve computed tomography.

Online medical information: A blessing or a curse?

The internet age has enabled patients to access a plethora of medical information. However, a potential drawback is that some of this information is inaccurate or misleading, causing unnecessary anxiety or false hope to patients.

Cardiac & Vascular Institute becomes first North Central Florida cardiologist group...

The Cardiac & Vascular Institute is the first organisation in the North Central Florida USA area of the USA to offer patients with non-valvular...

Percutaneous direct annuloplasty is “safe and feasible” for functional mitral regurgitation

Georg Nickenig and others report in the Journal of the American College of Cardiology that the Mitralign percutaneous annuoplasty system (MPAS, Mitralign) is a feasible and safe treatment for high-risk patients with functional mitral regurgitation.

First patient enrolled in Keystone Heart Triguard study

The device is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve implantation (TAVI), minimising the risk of cerebral damage. The study, REFLECT, is a multicentre, phase 2/3, randomised, interventional, single-blind clinical study.

Valcare completes first phase of first-in-human Amend trial

Valcare Medical, an Accelmed portfolio company has successfully completed the first phase of its first-in-human (FIH) multicentre clinical trial, taking place in Israel and Europe.

Transcatheter tricuspid valve repair successfully achieved in feasibility study of 4Tech...

4Tech has announced that its TriCinch device has been used to successfully treat patients suffering from tricuspid regurgitation. The ongoing feasibility study is being conducted at San Raffaele Hospital (Milan, Italy) and in other sites in Italy and Europe.

Investigational trial into Medtronic CoreValve Evolut R 34mm enrols first patient

PinnacleHealth (East Cowes, USA) has enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve Evolut R system, the Evolut R 34mm system.

Biotronik’s scaffold is now approved for use in Europe

Biotronik's bioresorbable magnesium scaffold, Magmaris, is now CE mark approved, meaning it is now one of three bioresorbable scaffolds available on the European market (alongside Abbott Vascular's Absorb and Elixir Medical's Desolve.

Minor short-term mortality benefit with vascular closure devices

Vasim Farooq and others report in Circulation Cardiovascular Interventions that the use of a vascular closure device after transfemoral PCI is associated with a minor short-term mortality benefit compared with manual compression.

Go “slender” to reduce the rate of radial artery occlusions

Giovanni Amoroso (Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands) is involved in developing the slender transradial interventions concept, which focuses on the maximal miniaturisation of transradial coronary interventions.

“Encouraging” results for transcarotid TAVI

Darren Mylotte and his co-authors report that TAVI with transcarotid access is "feasible and is associated with encouraging short- and medium-term clinical outcomes". In this interview, he explains the need for an alternative access approach to transfemoral and reviews the potential benefits of transcarotid access.

CE mark for longest version of Xposition S sirolimus-eluting stent

Stentys has announced that it has received the CE mark for the longest version (37mm) of its Xposition S sirolimus-eluting self-apposing stent. The approval of this longer version means that interventional cardiologists will now only need to implant a single self-apposing stent (in relevant longer lesions) rather than a long conventional stent, thus minimising the risk of malapposition and related complications.

NYU Langone becomes first centre in world to use Evolut PRO...

The Cardiothoracic Surgery Department's Heart Valve Center at NYU Langone Medical Center became the first centre in the world to implant a new heart valve for TAVI in a patient with severe aortic stenosis.

James Blankenship

James Blankenship is the 2015-2016 president of SCAI and has been involved with designing and implementing the society's new strategic plan. He talks to Cardiovascular News about the plan and how climbing Kilimanjaro with his three children was a good reminder of what matters most in life.

The risk of acute kidney injury during complex cardiac interventions: Rationale...

Although most patients undergoing complex cardiac or vascular interventions tolerate contrast, some will develop contrast-induced acute kidney injury-which is associated with increased mortality. In this commentary, Philippe Garot and Andrew Roy review the aims and objectives of the ongoing STRENGTH trial.

Reducing aggressive and rude communication helps both doctors and patients

While profoundly overworked clinical teams may understandably be reluctant to accept another referral, aggressive, rude or dismissive communication negatively affects both staff and patients. Benjamin C Whitelaw reviews the steps that can be taken to reduce such behaviour.

A new percutaneous approach for managing mitral valve regurgitation

Last year, the Cardioband mitral reconstruction system (Valtech) was approved in Europe for mitral valve repair. It joins MitraClip (Abbott Vascular) as one of the few options available for patients with mitral regurgitation who are unable to undergo surgery because of a high risk of complications.

Karl-Heinz Kuck steps down from the ESC and EHRA after fraud...

Karl-Heinz Kuck has withdrawn his candidacy for president-elect of the European Society of Cardiology (ESC) and also resigned from board of the European Heart Rhythm Association (EHRA). This follows a conviction for fraud.

A new percutaneous approach for managing mitral valve regurgitation

Last year, the Cardioband mitral reconstruction system (Valtech) was approved in Europe for mitral valve repair. It joins MitraClip (Abbott Vascular) as one of the few options available for patients with mitral regurgitation who are unable to undergo surgery because of a high risk of complications.

Marriage is good for the heart

Being married could improve your likelihood of surviving a myocardial infarction and is associated with reduced length of hospital stay, according to research presented at the British Cardiovascular Society (BCS) Conference (6–8 June, Manchester, UK).

Heart bleeds associated with severity of heart failure

The amount a heart "bleeds" following a myocardial infarction can predict the severity of future heart failure, according to research presented at the British Cardiovascular Society (BCS) conference (6–8 June, Manchester, UK). The researchers have now found that this injury is associated with a higher risk of developing heart failure in the months following a heart attack.

Permaseal transapical access and closure device now approved in Europe

Micro Interventional Devices has received the CE mark for its Permaseal transapical access and closure device. The device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium.

New “harvesting heroes” campaign to recognise work of healthcare professionals working...

In collaboration with APACVS, the Getinge Group has launched a new "Harvesting Heroes" campaign. The campaign seeks to recognise healthcare professionals in the field of cardiac surgery as well as celebrate 20 years since the endoscopic vessel harvesting technique was pioneered.

FDA streamlines “compassionate use” application process

The US Food and Drug Administration (FDA) has finalised its efforts to streamline the "compassionate use" process, used by physicians to access investigational drugs and biologics for patients with limited treatment options.

The Medicines Company completes patient enrolment for ORION-1 study of PCSK9si

Patient enrolment has been completed in The Medicine Company's ORION-1 study of PCSK9si, its investigational RNA interference (RNAi) proprotein convertase subtilisin/kexin type 9 synthesis inhibitor (PCSK9si).

Study shows women with migraines to be at higher risk of...

Women diagnosed with migraines have a slightly increased risk of developing cardiovascular diseases, such as heart attacks and strokes, and are somewhat more likely to die from these conditions than women who do not have migraine, according to findings of a large study published in The BMJ.

Lack of an on-site cardiac surgery department should not be a...

Holger Eggebrecht and others report in the European Heart Journal that the lack of an on-site cardiac surgery department should not be a contraindication to centres performing TAVI

CE mark granted to Occlutech left atrial appendage occluder

Occlutech has obtained European CE mark approval for its left atrial appendage, (LAA), occluder. The device is a specifically designed implant for the minimally invasive closure of the LAA, a procedure that minimises the risk of strokes in patients suffering from atrial fibrillation.

Philips Minicare I-20 handheld devices receives CE mark

Royal Philips has received CE marking for its cardiac troponin I (cTnI) blood test with the Minicare I-20 handheld device. Minicare cTnI is designed to deliver lab-comparable test results in less than 10 minutes.

BioVentrix receives FDA investigative device exemption for ALIVE trial of Revivent

BioVentrix has received US Food and Drug Administration (FDA) investigational device exemption approval to initiate its pivotal ALIVE (American Less Invasive Ventricular Enhancement) clinical trial.

European Union agrees new rules for approving medical devices and in...

The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

Trial shows Orsiro is non-inferior to Resolute Integrity

According to data presented at EuroPCR (17-20 May, Paris, France), a hybrid sirolimus-eluting stent (Orsiro, Biotronik) is non-inferior to a zotarolimus-eluting (Resolute Intergrity, Medtronic).

More data in support of newer generation stents for high bleeding...

Sara Ariotti, Marco Valgimigli and others report in JACC: Cardiovascular Interventions that a zotarolimus-eluting stent provides superior safety and efficacy compared with a bare metal stent in patients at high risk of bleeding. They talk to Cardiovascular News about the implications of these findings for the future use of bare metal stents.

Polymer-free coronary stent more effective and safer than bare metal stent...

Patients with acute coronary syndromes (ACS) who are at high risk for bleeding have significantly lower rates of target lesion revascularisation and fewer adverse events after undergoing percutaneous coronary intervention (PCI) with a polymer-free biolimus-A (BA9) drug-coated stent than with those receiving a bare metal stent in results from a sub-study of the LEADERS FREE trial reported for the first time in a late-breaker session at EuroPCR 2016.

New procedure uses heart rate to estimate life expectancy of infarct...

The heart rate may be an indicator of a person's life expectancy. A research team at the Technical University of Munich (Munich, Germany) has to this end analysed an effect which at first seems paradoxical: Minor irregularities in the heartbeat are indicative of a healthy body.

Direct Flow Medical reports DISCOVER trial three-year results

Direct Flow Medical presented three-year results from its prospective, multicentre DISCOVER Trial at the 2016 EuroPCR meeting in Paris.

Jury favours CardiAQ in dispute with Neovasc

A federal jury in Boston, USA, has returned a verdict in favour of Edward Lifesciences' CardiAQ in a lawsuit filed against a former service provider, Neovasc. The jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ's trade secrets, and breached its duty of honest performance to CardiAQ.

Medinol announces results for NIREUS trial of BioNIR stent

Medinol has announced that the BioNIR has met its non-inferiority primary end point of angiographic in-stent late loss at six months in the NIREUS trial. The prospective, multicentre, randomised, non-inferiority pivotal study compared it to Medtronic's Resolute Integrity stent.

Mitralign raises almost US$40 million in equity financing

Mitralign has raised US$39.8 million to date in a Series E equity round of financing. With the Series E financing raised, the company plans to pursue US and CE regulatory approval for the commercialisation of their Trialign system, in parallel with preparations for European commercial launch of their Mitralign percutaneous annuloplasty system.

ResMed announces primary results for CAT-HF sleep apnoea trial

ResMed has announced primary results from a multicentre, randomised controlled phase II trial-CAT-HF-presented at the European Society of Cardiology's 2016 Annual Heart Failure Congress.

Pooled trial results show positive outcomes for Keystone Heart’s TriGuard

Keystone Heart has announced that a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter valve implantation (TAVR) in USA and Europe, have shown that TriGuard cerebral protection significantly reduces stroke rate, lowers CNS infarction and reduces total lesion volume, without adversely impacting the safety of the TAVR procedure.

HeartFlow haemodynamic data may help predict coronary plaque rupture potential

First-in-human data presented at EuroPCR 2016 have demonstrated that haemodynamic data from HeartFlow may help predict which coronary plaques have the potential to rupture.

Alvimedica TNT session presented at EuroPCR

A session, sponsored by Alvimedica Medical Technologies, discussing treatment options for PCI in diabetic patients, took place at EuroPCR (16-20th May 2016, Paris, France).

St Jude Medical launches new Trifecta GT tissue valve in the...

St Jude Medical has launched the Trifecta valve with Glide Technology (GT) in the USA. The valve is designed for the treatment of patients diagnosed with unhealthy, damaged or malfunctioning aortic heart valves. It is intended to allow for an enhanced valve delivery method to ease implantation in challenging anatomies and during minimally invasive surgical approaches.

One-year paediatric feasibility study results published for Xeltis bioabsorbable graft

One-year follow-up results from a paediatric feasibility study of Xeltis bioabsorbable cardiovascular pulmonary graft have been presented as late-breaker at the 96th American Association for Thoracic Surgery annual meeting.

Corona Regional Medical Center installs Toshiba’s Vantage Titan and Aquilon Prime...

Corona Regional Medical Center (Corona, USA) has installed Toshiba's Vantage Titan 1.5 Tesla magnetic resonance imaging system. It has also chosen to feature the Aquilion Prime 160 and Aquilion Prime 40 computed tomography machines, also from Toshiba.

Study suggests major clinical benefit for left atrial appendage occlusion

St Jude Medical has announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which look at how St Jude Medical's fractional flow reserve (FFR) technology impacts patient outcomes in acute coronary syndrome and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment, were presented during hotline sessions.

iVascular completes recruitment of patients for ANCHOR clinical trial of Angiolite

Recruitment of patients for iVascular's ANCHOR clinical trial has been completed with 104 patients treated with the sirolimus eluting stent Angiolite. The first interim three-month data have been presented at EuroPCR Congress 2016.

Drug-coated balloon is viable alternative to drug-eluting stent

Results from the BIOLUX randomised control trial, which were presented at EuroPCR 2016, indicate that the Pantera Lux drug-coated balloon (Biotronik) is angiographically non-inferior to stenting with the latest-generation drug-eluting stents at six months for the treatment of in-stent restenosis.

Post-market study show “excellent” outcomes for Lotus TAVI valve

According to results of the RESPOND post-market study, the Lotus TAVI device is associated with-a press release reports-excellent safety and efficacy outcomes at 30 days post implantation.

Three-month data for Watchman show high success rate

New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). The data are from more than 1,000 patients, from across Europe, who received the device and focus on post-procedural drug regimen, impact of centre experience and peri-device leakage.

Edwards’ surgical heart valve innovations demonstrate positive patient benefits

Edwards Lifesciences has announced positive clinical trial results on two of its advanced innovations in surgical heart valves for the treatment of people with aortic valve disease. Data from three studies-COMMENCE, TRANSFORM and FOUNDATION-were presented as part of the late-breaking sessions at the American Association for Thoracic Surgery's (AATS) 96th annual meeting.

Sapien 3 demonstrates positive patient outcomes at 30 days in European...

Edwards Lifesciences has announced that 30-day data from its European post-approval study of the Sapien 3 transcatheter aortic heart valve demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries.

St Jude Medical launches PressureWire X Guidewire in Europe

St Jude Medical has announced CE mark approval and European launch of the PressureWire X Guidewire fractional flow reserve (FFR) Measurement System. Designed to identify the severity of narrowings in the coronary arteries of patients with coronary artery disease (CAD), FFR measurement allows for a more effective assessment of coronary lesions (blockages), resulting in more accurate diagnosis.

Major new study to investigate abbreviated DAPT in high bleeding risk...

At EuroPCR (17-20 May, Paris, France), a new global study that involves 4,300 patients from 34 countries was announced. The study, according to a press release, is set to shed light into the use of short duration DAPT in patients following stenting procedures, with a particular focus on those with a high bleeding risk.

Cordis to return to drug-eluting stent market following Biosensors agreement

Cardinal Health has entered into a distribution agreement with Biosensors that enables Cordis, Cardinal Health's interventional vascular business, to sell Biosensors' coronary stent portfolio.

Corvia Medical InterAtrial shunt device receives CE mark

Corvia Medical has been granted CE mark approval for its InterAtrial shunt device (IASD). The IASD is a transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure.

Young female acute coronary syndrome patients have significantly greater comorbidities than...

A study indicates that women aged less than 55 years with acute coronary syndrome undergoing percutaneous coronary intervention (PCI) have significantly greater comorbidities and worse outcomes than their male counterparts.

Study to directly compare Orsiro with Xience in STEMI patients

The first patient has been enrolled in Biotronik's new BIOSTEMI trial, which is evaluating the safety and efficacy of the Orsiro hybrid drug-eluting stent, compared with Xience Xpedition (Abbott Vascular), in patients with STEMI.

Admedus to attend upcoming US heart conferences

Admedus will be attending the American Association for Thoracic Surgery (AATS) Aortic Symposium 2016 May 12-13 in New York City, USA and the 96th AATS Annual Meeting taking place from 14-18 May in Baltimore, USA.

Medicure files application for new tirofiban hydrochloride product format

Medicure has submitted an application to the US Food and Drug Administration (FDA) for the introduction of a new "bolus vial" product format for tirofiban hydrochloride monohydrate (HCl), trading under the name Aggrastat.

Device reduces volume of radiographic dye in patients at risk of...

In the largest study of its kind, the Avert device from Osprey Medical has been found to significantly reduce the volume of radiographic dye without decreasing image quality in patients who are at risk of developing acute kidney injury after undergoing a coronary angiography or percutaneous coronary intervention.

No gender-based outcomes variation for two anticoagulants in TAVR patients

A study on the impact of using different anticoagulation medications on men and women who have undergone a transcatheter aortic valve replacement (TAVR) has found no difference in early vascular complications or mortality.

NICE recommends evolocumab for some patients at high risk of cardiovascular...

NICE has published a recommendation supporting the use of evolocumab alone or in combination with other cholesterol-lowering therapies, for several types of patients at particularly high risk of cardiovascular events with persistently high cholesterol.

Optical coherence tomography helps cardiologist predict significant side branch ostium stenosis

In a new study using optical coherence tomography (OCT), researchers have found that maximum lipid arc and the presence of lipid plaque contralateral to the side branch (SB) ostium before stenting may contribute to significant side branch ostium stenosis (SBOS) after stenting.

Robotically-assisted percutaneous coronary intervention feasible in complex cases

A first-of-its kind study using robotic technology to remotely control coronary guidewires and stents reported on the feasibility of performing percutaneous coronary intervention (PCI) on patients with complex coronary lesions. Similar clinical outcomes compared to the PCI procedure performed manually were reported.

Exploring the role of P2Y12 inhibitor monotherapy after dual antiplatelet therapy

According to Usman Baber, TWILIGHT is a unique and innovative study in that the experimental intervention is to withdraw rather than add to existing background pharmacotherapy. In this commentary, he explores the aims and goals of the study.

First central Pennsylvania, USA, patients receive new aortic valve reconstruction procedure

Three PinnacleHealth patients have undergone a new procedure for aortic valve reconstruction, using the patients’ own heart tissue (pericardium) to create the new valves.

Konica Minolta release updated Sonimage HS1 compact ultrasound

Konica Minolta have introduced a new version of the Sonimage HS1 compact ultrasound system, which is designed to enable improved image quality.

Patient enrolment completed in REDUCE trial

Enrolment in the REDUCE trial-a physician-initiated, prospective, multicentre, randomised study, designed to evaluate the potential for shorter-term dual antiplatelet therapy (DAPT) in acute coronary syndrome-has reached completion, according to an OrbusNeich press release.

Abbott to acquire St Jude Medical

Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure as well as neuromodulation. The combined company will thus produce devices across cardiovascular, diabetes, vision and neuromodulation markets.

Enrolment completed in BIOFLOW-V clinical study or Orsiro

Biotronik has announced that enrolment in its BIOFLOW-V clinical study has been completed. The company reports that 1,334 patients have been enrolled at 91 sites in the US, Canada, Europe, Israel, and the Asia Pacific region in under a year.

Transcatheter technologies sells its technology portfolio to Venus MedTech

Transcatheter Technologies GmbH, a medical device company that has developed a full range of transcatheter valve implantation systems for catheter-based heart valve therapy, has sold its technology portfolio to Venus Medtech.

Study finds reasons for hospital-level variations in bleeding post-angioplasty remain unclear

The use of bleeding avoidance strategies has only a modest effect on the variation in bleeding rates post-angioplasty among hospitals performing this procedure, leaving about 70% of the causes for this variation unexplained, according to a study published in JACC: Cardiovascular Interventions.

Scientists report on novel method for extending the life of implantable...

In a paper published in Nature Communications, investigators from Harvard report on a novel biochemical method that enables the rapid and repeated regeneration of selected molecular constituents in situ after device implantation, which has the potential to substantially extend the lifetime of bioactive films.

Toshiba’s Aquilion Lightning CT with more powerful generator receives FDA clearance

Toshiba America Medical Systems'sAquilionTM Lightning has been cleared by the US Food and Drug Administration (FDA) with a more powerful 50-kW generator.

Admedus expands distribution agreement with Coroneo

Admedus has expanded its distribution partnership with Coroneo to sell its Extra-Aortic Annuloplasty Ring and related products in Australia and New Zealand. According to a press release, Admedus anticipates gaining marketing approval for this unique aortic implant in the second half of 2016.

French hospital celebrates 30 years of implanting artificial hearts

La Piti̩-Salp̻tri̬re Hospital (Paris, France), the world's leading artificial heart centre, is celebrating the 30th anniversary of the first Total Artificial Heart implantation. The centre has now performed 249 implants of the SynCardia Total Artificial Heart and has implanted more of the devices than any other medical centre in the world.

Boston Scientific voluntarily recalls Fetch 2 aspiration catheter

Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 aspiration catheter. A press release reports that the catheters were recalled on 22 March 2016 because of complaints of shaft breakage.

Impella can now be used in USA for cardiogenic shock after...

Abiomed has received FDA pre-market approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps for the treatment of ongoing cardiogenic shock. This latest approval adds to the prior FDA indication of Impella 2.5 for high risk percutaneous coronary intervention (PCI), or Protected PCI.

Boston Scientific is suspending sales of Watchman FLX in Europe

According to a Reuters news report, Boston Scientific is temporarily suspending sales of Watchman FLX-the next-generation system of its left atrial appendage closure device, Watchman.

St Jude Medical launches Trifecta surgical valve in Europe

A press release reports that the new Trifecta valve with glide technology provides enhanced valve delivery designed to improve implantation during both minimally invasive and conventional valve replacement procedures.

4Tech appoints Paul Cornelison as Global Vice President of Regulatory Affairs,...

4Tech, which is developing a transcatheter device (TriCinch) for repair of the tricuspid valve, has announced that it has appointed Paul Cornelison, as Vice President of Regulatory Affairs, Quality Assurance & Clinical Affairs.

Deferred stenting in STEMI patients does not improve outcomes

A study indicates that delaying stenting-compared with conventional PCI-in patients with STEMI does not reduce the risk of death, heart failure, myocardial infarction, or repeat revascularisation.

New sub-analyses show benefit of long-term use of ticagrelor for high-risk...

AstraZeneca has announced results of two separate sub-analyses of PEGASUS-TIMI 54, which investigated the long-term use of ticagrelor (Brilinta) tablets in patients with a history of myocardial infarction and at least one additional risk factor for thrombotic cardiovascular events at three years.

Early data show good rapid healing for Medtronic’s investigational drug-filled stent

One-month, follow-up patient cohort data from the Revelution trial of Medtronic's novel drug-filled stent indicate that device is associated with rapid vessel healing without inflammation, as assessed by OCT.

One-year data for FFRCT support previous findings

According to one-year data, FFRCT (HeartFlow) significantly reduces the need for invasive procedures to diagnose patients suspected of having coronary artery disease and also leads to a sustained reduction in the cost of care.

Positive early feasibility data for pulmonary valve restoration with transcatheter pulmonary...

Clinical data, from an early feasibility study, indicate that Medtronic's Harmony transcatheter pulmonary calve is associated with positive initial outcomes at six-months in patients with an indication for pulmonary valve restoration.

More than 5,000 patients enrolled in iFR outcome trials

More than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions iFR pressure measurement technology compared with FFR measurements.

CoreValve still better than surgery at three years in high-risk patients

TAVI with CoreValve (Medtronic) continues to be associated with significantly better outcomes than surgery at three years in high-risk patients. Previously published data for the device have indicated that it has better outcomes at one and two years after the index procedure.

The role of sutureless and rapid-deployment valves

Antonio Miceli explores the data for sutureless and rapid-deployment surgical valves for the management of patients with severe aortic stenosis. He also reviews the place of these new devices alongside traditional surgical valves and TAVI devices.

Toshiba to showcase Aquilion ONE family technology at the 2016 ACC...

Toshiba will showcase its Aquilion ONE family of computed tomography (CT) systems at this year's American College of Cardiology (ACC) annual meeting in Chicago, USA, April 2-4, 2016. The systems are designed to improve workflow and make TAVR planning more efficient.

First patients enrolled in Medtronic CoreValve Evolut R trial in low-risk...

The first patients have been enrolled in the expanded indication trial for the CoreValve Evolut R next-generation, recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system from Medtronic. This clinical trial will include 1,200 patients with severe aortic stenosis who have a less than 3% risk of operative mortality.

Two new publications report on use of PleuraFlow technology

Cardiac surgeons at the Montreal Heart Institute have published a case report featured in the Annals of Thoracic Surgery, shortly after the publication of a new study in the Journal of Thoracic and Cardiovascular Surgery by independent investigators in Germany.

New ultrasound method creates better picture of cardiovascular health

Six years ago, a handful of researchers at Lund University in Sweden started taking an interest in how to make it easier to recognise unstable plaques that in worst case scenarios rupture and cause heart attacks or strokes.

First patient enrolled in Xenios i-cor cardiac assist system trial

The first patient has been enrolled in the SynCor clinical trial of Xenios' i-cor synchronised cardiac assist system for treating cardiogenic shock. The SynCor trial is a study of the safety and performance of the i-cor System in 45 consecutively enrolled patients.

US FDA grants Humanitarian Use Device status for Xeltis pulmonary valve

The US Food and Drug Administration has granted Humanitarian Use Device designation for Xeltis' bioabsorbable cardiac pulmonary valve, for the correction or reconstruction of right ventricular outflow tract.

Direct Flow Medical launches next generation TAVI delivery system

Direct Flow Medical has launched the DirecTrack delivery system in Europe. DirecTrack is a next generation delivery system for the Direct Flow Medical transcatheter aortic valve system.

Boston Scientific to present data at American College of Cardiology Scientific...

Boston Scientific is to present data spanning its interventional cardiology, rhythm management and structural heart portfolios at the American College of Cardiology’s 65th Annual Scientific Session which will be held in Chicago, USA, April 2-4.

Heart attack patients becoming younger and more obese

Despite increased understanding of heart disease risk factors and the need for preventive lifestyle changes, patients suffering the most severe type of heart attack have become younger, more obese and more likely to have preventable risk factors.

Signs of stress in the brain may signal future heart trouble

Signs of stress in the brain have been associated with inflammation in the arteries. Individuals with these signs may be at higher risk for cardiovascular events, including heart attack, stroke and death, according to a study scheduled for presentation at the American College of Cardiology's 65th Annual Scientific Session.

The Medicines Company to present antithrombotic agent data at 2016 ACC...

Investigators will present new analyses from high-risk percutaneous coronary intervention (PCI) patient subgroups from the CHAMPION PHOENIX study with The Medicine Company's antithrombotic agent, Kengreal (cangrelor) for injection.

American College of Physicians recommends prescription drug pricing changes

The American College of Physicians (ACP) has released a new policy paper calling for changes that could slow the rising cost of prescription drugs in the USA. The paper was published in Annals of Internal Medicine.

Implantation height affects rate of pacemaker implantation with Sapien 3

Fernando De-Torres-Alba and others report in JACC: Cardiovascular Interventions that a significantly higher rate of pacemaker implantation with Sapien 3 compared with Sapien XT relates to the implantation height of the newer device.

Enrolment complete for MiStent optical coherence tomography study

The MiStent Sirolimus eluting absorbable polymer coronary stent system (MiStent SES) optical coherence tomography (OCT) study has completed enrolment, according to a press release from Micell Technologies.

Stentys Xposition S self-apposing stent receives CE mark for unprotected left...

The Xposition S (Stentys), a sirolimus-eluting self-apposing stent, has received CE marking for the treatment of unprotected left main coronary artery disease.

PCI does not reduce readmission rates for patients with syncope and...

Lindsay Anderson and others report that, compared with medical management, PCI is not associated with a significant reduction hospital readmission for syncope in older patients with syncope and obstructive coronary artery disease.

Sapien 3 now approved for use in Japan

Edwards Lifesciences has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its Sapien 3 transcatheter heart valve for the management of severe, symptomatic aortic stenosis.

OptoWire II FFR guidewire receives FDA 510(k) clearance

Opsens has received 510(k) clearance from the FDA for OptoWire II-an optical guidewire developed to measure fractional flow reserve (FFR). The company has already received FDA clearance to sell the OptoWire I, the first generation of its optical guidewire.

First patient receives CorMatrix’s ECM tricuspid valve

According to CorMatrix, a patient has become the first person to receive the company's tissue-engineered regenerative Tricuspid Valve. The operation was performed by Marc Gerdisch, who was implanting the valve as part of CorMatrix's investigational device exemption (IDE)-feasibility study of the device.

Adults with congenital heart disease may be at increased risk of...

A single-centre study from The Children's Hospital of Philadelphia (CHOP) indicates that as many as one in five adult patients with congenital heart disease have symptoms of post-traumatic stress disorder (PTSD).

The SCOUT study: Transcatheter tricuspid repair

Rebecca Hahn is the principal investigator of the SCOUT trial, which is evaluating the use of Mitralign's transcatheter tricuspid repair system for the management of tricuspid regurgitation. She reviews the potential role of the Mitralign system in treating these patients.

Abbott Vascular recalls MitraClip clip delivery system

Abbott Vascular has recalled the MitraClip clip delivery system, following reports of issues with the delivery system deployment process.

Stenting of narrow pulmonary artery benefits patients with congenital heart disease

The use of a stent to repair pulmonary artery stenosis in children and adults with congenital heart disease was successful in the majority of patients according to new research.

Study suggests no advantages with surgical approach for transfemoral TAVI

James M McCabe and others report that surgical access for transfemoral transcatheter aortic valve implantation (TAVI) is not associated with a significant reduction in major vascular complications compared with percutaneous access.

Magnesium Elektron and Biotronik develop bioresorbable magnesium coronary scaffold

Magnesium Elektron and Biotronik have partnered to develop the SynerMag bioresorbable magnesium alloys for applications in cardiovascular medicine. The joint research and development program began in 2006, with the aim of developing a bioresorbable magnesium coronary scaffold.

Successful PCI of chronic total occlusions does not improve long-term survival

Pil Hyung Lee and others report that successful PCI of a native chronic total occlusion lesion is not associated with improved long-term survival compared with a failed procedure.

Women less likely to receive basic life support for cardiac arrest...

Women are less likely to receive basic life support for cardiac arrest from members of the public then men according to a study, the European Society of Cardiology announced on the 2016 International Women's Day.

Corvia Medical receives FDA investigational device exemption approval for REDUCE LAP-HF...

Corvia Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a multicentre clinical study of the company's InterAtrial shunt device (IASD) for the treatment of heart failure.

Palmaz Scientific seeking prospective buyers following bankruptcy announcement

Palmaz Scientific has filed for chapter 11 bankruptcy protection in San Antonio. According to a company release, this action has been taken to provide adequate time to identify and evaluate prospective buyers for its metallurgical medical device technology.

First patients enrolled in CoreVavle Evolut R real-world study

The first patients have been enrolled in the FORWARD clinical study, which will evaluate performance outcomes associated with the use of the Medtronic CoreValve Evolut in everyday clinical practice, is global, multi-centre, single-arm and prospective. It aims to enrol up to 1,000 patients.

Alexandra Lansky

Alexandra Lansky (Director, Heart and Vascular Clinical Research Program, Yale University School of Medicine, New Haven, USA) talks to Cardiovascular News about what she feels have been the most important clinical breakthroughs in interventional cardiology and what she thinks the next big innovation will be.

Edwards Sapien XT valve granted expanded FDA approval for pulmonic procedures

Adult and paediatric patients presenting with either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease are now approved for treatment by the Sapien XT valve.

Abbott issues voluntary safety notice on MitraClip delivery system deployment process

The company has received nine Medical Device Reports of malfunction involving MitraClip delivery systems, in which the user was unable to separate the implantable clip from the delivery system.

Long-term results “will prove in favour” of specific device for closing...

A new study has found no significant difference in outcomes between a specifically-designed transcatheter paravalvular leak closure device and other closure devices. Authors claim that the benefit of the specific device will be seen in the long term.

First J-Valve TAVI system implanted outside of China

The J-Valve system (JC Medical) is a next-generation transcatheter aortic valve implantation system, which has been previously used in more than 100 patients in China.

Carillon mitral contour system associated with significant improvement of functional mitral...

A single-centre study published in the Journal of Invasive Cardiology noted that treatment with Cardiac Dimensions' Carillon mitral contour system resulted in significant improvement of functional mitral regurgitation.

Corindus appoints Mark J Toland as president and chief executive officer

Corindus Vascular Robotics has appointed announced Mark Toland as chief executive officer and member of the Board of Directors. He replaced David Handler, who has announced his resignation. Toland brings over 20 years of experience in the cardiovascular medical device industry.

REVA reaches target patient enrolment in FANTOM II trial

FANTOM II is a clinical study of the safety and performance of the Fantom sirolimus-eluting bioresorbable coronary scaffold. A total of 227 patients have been enrolled at clinical sites in eight countries outside of the USA.

Tirofiban hydrochloride meta-analysis presented at CRT 2016

A meta-analysis of tirofiban hydrochloride (Aggrastat, Medicure) has been presented by primary investigator and lead author, Michael J Lipinski of the MedStar Heart and Vascular Institute, Washington, DC, presented the data at the 2016 Cardiovascular Research Technologies (CRT) conference.

Mitralign percutaneous annuloplasty system granted CE mark for functional mitral regurgitation...

The Mitralign percutaneous annuloplasty system (MPAS) has received CE mark approval from the British Standards Institution for the treatment of functional mitral regurgitation (FMR). The product can now be marketed within the European Union.

ReCor Medical receives IDE approval for RADIANCE-HTN hypertension clinical trial

ReCor Medical has been granted US Food and Drug Administration investigational device exemption approval for the RADIANCE-HTN clinical trial. This trial will measure the effect of ReCor's Paradise renal denervation system on blood pressure, in patients with hypertension.

Expanded CE mark approval for Z-Medica QuikClot

Z-Medica has been granted an expanded CE mark for the QuickClot products within the European Union (EU), bringing its indications for use in line with those in the USA.

TherOx adds Keith Grossman to board of directors

TherOx' SSO2
Grossman has over 30 years of experience in the medical device field, most recently, and for the second time, as the president, chief executive officer and director of Thoratec Corporation, up to its 2015 sale to St Jude Medical.

Cardiovascular Systems report 30-day results of COAST trial

Thirty-day results of Cardiovascular System's Coronary Orbital Atherectomy System Study (COAST) have been reported at a late-breaking presentation at the 2016 Cardiovascular Research Technologies Conference in Washington, USA.

Second USA minimally invasive Trialign procedure performed in Chicago

Interventional cardiologists at Northwestern Memorial Hospital, Chicago, USA have become the first in the mid-west of the USA, and the second nationally, to perform a minimally invasive tricuspid valve procedure using the Mitralign Trialign system.

First UK Revivent-TC transcatheter ventricular enhancement procedure performed

The first clinical use of BioVentrix's closed-chest Revivent-TC transcatherter ventricular enhancement system in the UK has taken place at Freeman Hospital, Newcastle-upon-Tyne. The less invasive ventricular enhancement (LIVE) procedure is used in the treatment of ischaemic cardiomyopathy.

Complete PCI in STEMI: An interventional paradigm shift

In a new focused update, the ACC/AHA/SCAI now recommend that complete PCI is acceptable in some patients with STEMI with multivessel disease. Eliano P Navarese reviews the evidence base for complete PCI compared with culprit-artery only PCI.

Medtronic can now investigate CoreValve Evolut R in low-risk patients

Medtronic has announced that the FDA has approved an expanded indication trial for the CoreValve Evolut R system, which enables the TAVI device to be investigated in patients with aortic stenosis who are at a low surgical mortality risk as determined by a heart team.

First patient enrolled in study of supersaturated oxygen system for acute...

The investigational device exemption confirmatory study will investigate the ability of SSO2 therapy to reduce infarct size after AMI, and is being conducted to support a premarket approval submission to the US Food and Drug Administration.

Effects of the Paris attacks on cardiovascular hospitalisation in Toulouse

Observing a sharp increase in admissions in their cardiovascular unit directly following the 2015 Paris attacks, Atul Pathak and his team hypothesised that the sudden increase of activity in their department might be stress-induced.

First two patients treated in study of Peregrine system for renal...

The first patients were treated at an American Heart of Poland hospital in Poland, using the Peregrine system infusion catheter (Ablative Solutions) with a neurolytic agent to treat sympathetic nerves in the outer layer of the renal arteries.

Direct Medical Flow announce transcatheter mitral valve development program

The mitral valve is designed to feature a low atrial profile, low ventricular projection and conformable sealing and fixation rings for the complex mitral annulus. This announcement took the form of a preclinical case presentation of the Transcatheter mitral valve.

Heart attack patients with cardiogenic shock fair well from 60 days...

Heart attack patients who experience cardiogenic shock have a higher risk of death or rehospitalisation than non-shock patients in the first 60 days post-discharge. By the end of the first year, however, the gap between the two groups narrows, according to a new study in the Journal of the American College of Cardiology.

Makkah’s cardiac hospital describes how it copes with yearly pilgrimage

There is a huge influx of patients every year to Makkah (Mecca), Saudi Arabia, during the Hajj. Makkah's cardiac hospital describes how it copes with this, and gives details of its echocardiography service in an abstract presented at the 27th Annual Conference of the Saudi Heart Association.

Acute vessel wall injury is common after transradial catheterisation but is...

Acute vessel wall injury is common after transradial catheterisation but it is not associated with an increased risk of radial artery occlusion or loss of radial artery pulsation, according to a report published in Circulation: Cardiovascular Interventions.

More than 200 patients have been enrolled in Reva Medical’s study...

Reva Medical has announced that more than 200 patients have been enrolled in its clinical study of its sirolimus-eluting bioresorbable coronary scaffold (Fantom).

NeoChord receives German NUB status 1 for DS1000 mitral valve repair...

The NUB (Neue Untersuchungs- und Behandlungsmethoden) process enables the introduction of new medical products prior to formal reimbursement eligibility and introduces the cost of a new procedure into the German reimbursement system.

European Society of Cardiology announces winners of innovative cardiovascular research grant...

The 'Grants for Medical Research Innovation' are awarded to research projects that will address areas of unmet medical need in thromboembolic disease.

CorMatrix Cardiovascular receives 510(k) clearance for the Tyke implantable device for...

CorMatrix Cardiovascular has received 510(k) clearance from the US Food and Drug Administration for its CorMatrix Tyke, a biomaterial technology derived from the company's extracellular matrix biomaterial technology platform.

Valtech Cardioband reconstruction system for mitral valve repair receives reimbursement in...

Valtech has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 approval for the Cardioband mitral reconstruction system, its flagship device for addressing mitral regurgitation in heart failure patients.

FDA Advisory Committee to review AngelMed Guardian system for pre-market approval

The Circulatory System Devices Panel of the US Food and Drug Administration will review Angel Medical Systems' premarket approval application for the AngelMed Guardian system at a meeting on the 16 March 2016.

Admedus appoints Wayne Peterson as new chairman of the Board

Wayne Paterson has been appointed as non-executive chairman of the Admedus Board of Directors, with immediate effect. This follows the resignation of Chris Catlow who held the position for five years.

First patient enrolled in trial of the COBRA PzF nanocoated coronary...

The first patient has been enrolled in CeloNova BioSciences' COBRA REDUCE trial, which will study the Cobra PzFTM nanocoated coronary stent system in patients at a high risk of bleeding. The trial recently received conditional US Food and Drug Administration approval.

St Jude Medical launches Optis mobile system in Japan and Europe

The diagnostic system is designed to couple optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) technology into one portable system for hospitals with multiple catheterisation labs.

US Medicare to cover Boston Scientific Watchman left atrial appendage closure...

The US Centers for Medicare and Medicaid Services (CMS) are to cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency's final National Coverage Determination (NCD).

Corindus appoints Campbell Rogers to its Board of Directors

Rogers has served as chief medical officer of HeartFlow since 2012. He has also conducted extensive clinical research including serving as principal investigator for numerous interventional cardiology device, diagnostic and pharmacology trials.

Clive Meanwell of The Medicines Company receives innovation and leadership award

Clive Meanwell, the founder and chief executive of The Medicines Company, has received the 2016 Sol J Barer Award for Vision, Innovation and Leadership.

Building the ideal heart team for transcatheter mitral valve interventions

In this commentary, Vinayak Bapat outlines transcatheter mitral valve interventions and reviews which specialists should comprise the optimal heart team for such procedures.

Alexander J Denner appointed to The Medicines Company Board of Directors

Denner will serve as a class III director, with a term expiring at the company's 2018 Annual Meeting of Stockholders. He will also serve on the Company's Nominating and Corporate Governance Committee.

CorMatrix Cardiovascular prosthetic heart valve platform receives 27th patent

CorMatrix Cardiovascular's prosthetic heart valve platform has been issued US Patent No. 9,226,821, bringing the total number of issued patents relating to this platform to 27. Thirty patents are pending in the US and internationally.

Admedus CardioCel achieves first sales in Middle East and North Africa...

The initial sales of CardioCel have come through an early access program in Qatar. Admedus anticipates additional sales in other MENA countries in the near future.

New sizes of the Medtronic launches new Resolute Onyx drug-eluting stent...

The new sizes-4.5mm and 5mm-have recieved CE mark, along with several new product indications including treatment of left main vessels and small vessels.

OrbusNeich highlights new generation coronary balloons at AsiaPCR/SingLIVE 2016

The Case-in-Point session, 'Your complex PCI: How can new technologies enhance procedural success?', reviewed solutions for calcified lesions with complex anatomy, where the dual wire Scoreflex balloon can be used as an alternative to rotablation.

Admedus signs distribution agreement with Coroneo

Admedus has entered into an exclusive distribution agreement with Canadian company Coroneo to sell its Aortic Annuloplasty Ring and a range of specialised surgical instruments for heart valve surgery in Germany and the UK.

Boston Scientific and Accenture develop data-driven digital health platform to improve...

The platform, called Advantics Care Pathway Transformation, is designed to help improve patient outcomes and reduce costs to treat patients with chronic cardiovascular diseases.

New AHA statement says symptoms of myocardial infarction may differ in...

In a new scientific statement, the American Heart Association advises that the causes, symptoms, and outcomes of myocardial infarction may be different in women compared with men. It adds that these differences are further pronounced in Black and Hispanic women

Non-transfemoral access is strongly associated with post-TAVI delirium

Masieh Abawi and others report in JACC Cardiovascular Interventions that about 13% of patients develop postoperative delirium after undergoing transcatheter aortic valve implantation (TAVI).

Roxwood Medical launches Micro14es extra support catheter

Micro14es is an extension of the Micro14 catheter, intended for complex peripheral and coronary disease. It is designed to provide enhanced guidewire support through challenging and tortuous anatomy.

RenalGuard Solutions announces new European clinical trial to evaluate long-term impact...

RenalGuard Solutions has announced the STRENGTH trial, designed to evaluate the long-term clinical and economic impact of RenalGuard therapy in patients at high risk for contrast-induced acute kidney injury (CK-AKI), which will begin later this year.

JenaValve Technology appoints Pieter Van den Steen as chief commercial officer,...

Prior to his current appointment, Van den Steen served as the commercial leader of Boston Scientific's Peripheral Interventions division in Europe, after being the general manager for one of their European regions.

The patient mind: Before, during & after heart surgery

In this Heart Valve Surgery Resources video, Kim Feingold and Duc Thinh Pham (both Northwestern Medicine, St Albans City, USA) discuss cardiac behavioural medicine for patients undergoing heart valve surgery.

Training is the key to wider adoption of the transradial approach...

This commentary explores why the USA, despite the data supporting the transradial approach, has been more reluctant than other countries to adopt the approach.

Reva hires Richard Kimes as senior vice president of Operations

Richard Kimes has joined Reva Medical as the company's senior vice president of operations. He is now responsible for leading manufacturing-related activities in support of the launch of sirolimus-eluting bioresorbable coronary scaffold, Fantom, in international markets.

Svelte Medical Systems announces European launch of Slender IDS

The Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system is to be launched commercially to select European accounts specialising in transradial intervention.

Valentin Fuster awarded Spain’s highest civilian award for services to healthcare

Valentin Fuster, editor-in-chief of the Journal of the American College of Cardiology has been awarded the Gran Cruz de la Orden Sanidad (Grand Cross of the Civil Order of Health) by the Spanish government.

One-hour diagnosis of heart attack possible with Roche troponin T test

Data from the TRAPID-AMI clinical study have confirmed the troponin T high-sensitivity test from Roche as an approach which can offer a more rapid diagnosis of heart attack in patients with acute chest pain.

Conavi Medical receives FDA 510(k) clearance for Foresight intracardiac echocardiography system

The product has been cleared for intracardiac and intraluminal ultrasound visualisation of cardiac and great vessel anatomy, as well as visualisation of other devices in the heart and great vessels of patients.

Edwards can expand Sapien 3 study indications following FDA approval

The FDA has given Edwards Lifesciences approval for an expanded indication study of its Sapien 3 valve. The IDE study will enrol elderly patients with severe, symptomatic aortic stenosis who are at low risk for surgery.

Japanese Ministry of Health, Labour and Welfare approve Occlutech atrial septal...

This product is indicated for the minimally invasive closure of atrial septal defects (ASD). The approval has been made possible by a partnership between Occlutech and Japan Lifeline.

SurModics acquires NorMedix, a company focused on minimally invasive catheter technologies

This acquisition is intended to bolster SurModic's vascular device expertise and research and development capabilities.

Expert consensus statement for treatment of cardio-oncology patients released by the...

The statement is intended to provide cardiologists, oncologists and internal medicine physicians with guidance for treating patients facing both cardiovascular disease and cancer.

Retrograde coronary revascularisation in Europe to treat chronic total coronary occlusions

Alfredo R Galassi reports on the use of PCI with the retrograde approach for the management of CTOs in Europe and how the Euro CTO Club and Live Summit are spreading the knowledge of new complex PCI techniques for CTOs.

The Medicines Company advances clinical development of investigational PCSK9 synthesis inhibitor...

The Medicines Company has initiated study sites, and begun enrolling patients, in the ORION-1 phase 2 study. ORION-1 will compare the effects of differenct ALN-PCSsc doses.

HeartWare appoints Stephen Oesterle to board of directors

HeartWare International has appointed Stephen Oesterle to its board of directors. Oesterle's career in cardiology and medical devices has spanned over 30 years, including senior leadership roles at Medtronic.

Vivasure granted CE mark for world’s first fully bioabsorbable percutaneous closure...

Vivasure Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies.

Clinical results of Chocolate Heart drug-coated coronary balloon announced by QT...

QT Vascular and its subsidiaries have announced the release of the initial results from the first-in-human (FIH) study of its unique drug-coated balloon, Chocolate Heart.

New coronary congenital disease classification suggested to aid identification of secondary...

A new classification of coronary congenital diseases has been suggested to help surgeons identify secondary defects in the operating theatre. The scheme is outlined in a novel European Society of Cardiology (ESC) position paper published today in Cardiovascular Research.

Orsiro may provide benefit over Xience for STEMI patients

A pre-specified substudy of BIOSCIENCE, published in EuroIntervention, has found that Orsiro is associated with a significantly lower rate of target lesion failure than is Xience in STEMI patients at one year.

Hyperglycaemia could lead to heart attack complications

The mechanism by which blood glucose levels can affect the contraction of blood vessels has been demonstrated for the first time by a team from the University of Leicester, UK.

Longer treatment times found for heart attack patients with history of...

Heart attack patients who have previously had coronary artery bypass graft surgery may be less likely than other heart attack patients-including those with prior angioplasty-to be treated within the recommended "door-to-balloon" time.

Seeking treatment earlier may improve heart attack outcomes

Patient delays have been associated with an increase in damage to the heart, according to a study published online in JACC: Cardiovascular Interventions.

Risk of cardiovascular events and death minimised by greater reduction of...

Researchers have recommended that blood pressure-lowering drugs should be offered to all people at a high risk of heart attack of stroke, regardless of their blood pressure at the start of treatment.

MicroPort EP completes first clinical case observation on its cardiovascular catheter...

MicroPort EP completes first clinical case observation on its cardiovascular catheter sheath

Coronary heart disease patients with no teeth have nearly double the...

A study from Uppsala, Sweden has found a linear association between levels of tooth loss and increasing death rates across 15,000 patients from 39 different countries.

HeartWare International receives director nominations notice from Engaged Capital

The company has also responded to comments from Engaged Capital, a new stockholder, regarding its proposed acquisition of Valtech Cardio.

AdvaMed, MITA & MDMA applaud congress for passage of the medical...

The Advanced Medical Technology Association (AdvaMed), the Medical Imaging & Technology Alliance (MITA) and the Medical Device Manufacturers Association (MDMA) have applauded the US Congress for their passage of a two year suspension of the medical device excise tax, in year-end legislation.

Edward Heart Hospital becomes first in Illinois, USA to use CorPath...

The CorPath system is designed to allow interventional cardiologists to perform procedures away from the patient bed side and the radiation source.

OrbusNeich’s new generation coronary balloons showcased at GulfPCR-GIM 2015

OrbusNeich presented the Sapphire II Pro and Scoreflex products at a case-in-point session at the course in Dubai, UAE.

GulfPCR explores transformative learning

Jean Marco, PCR honorary chairman, discussed "transformative learning" during a keynote lecture at the 2015 GulfPCR meeting.

The role of psychological support after a myocardial infarction

This commentary reviews the benefits of providing psychological support for patients who experience emotional distress after having a myocardial infarction.

Radial access used less than femoral approach for emergency angioplasty

This is in spite of the fact that using the radial artery as the access point for angioplasty is associated with less bleeding than use of the femoral artery.

Xeltis extends series B financing to €30 million

This €3 million extension is intended to hasten Xeltis' pipeline development on a number of cardiovascular indications.

CE mark for Svelte Medical’s sirolimus-eluting coronary stent-on-a-wire integrated delivery system

Svelte Medical Systems has received the CE mark for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system for the treatment of coronary artery disease.

Gregory D Casciaro becomes president and chief executive officer of Cardiac...

Cardiac Dimensions has announced the appointment of Gregory D Casciaro as president and chief executive officer, effective immediately. He will also become a member of Cardiac Dimensions' board of directors.

Mind the gender gap: Addressing inequalities in interventional cardiology

With only 4.5% of US interventional cardiologists being female, Cardiovascular News reviews the steps being taken to ensure that being female is not a barrier to being an interventional cardiologist.

Optimism associated with reduced cardiac readmission after acute coronary syndrome

Optimism after acute coronary syndrome has been found to be an independent predictor of both increased physical activity and reduced cardiac readmission. However, gratitude does not appear to affect these outcomes.

Roxwood Medical announces full US launch of its MicroCross catheter

Roxwood Medical has said now that more than 500 patients have been successfully treated with its MicroCross catheter (as part of an initial limited release), it is now going to fully launch the catheter in the USA

Edward Lifesciences announces further investments into mitral valve therapies

Edwards Lifesciences announced a structured investment in Harpoon Medical, which is pioneering a beating-heart, transcatheter therapy for minimally invasive surgical repair of a degenerative mitral valve.

i-cor synchronised cardiac assist preserves left ventricular function compared with continuous-flow...

A new study indicates that the i-cor synchronised cardiac assist system protects left ventricular function compared with continuous-flow extracorporeal life support in cardiogenic shock.

New study will evaluate Heart Test Laboratories’ MyoVista heart screening device

Heart Test Laboratories has announced the start of a clinical study of its MyoVista device by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed).

US cardiovascular societies publish joint expert consensus on left atrial appendage...

SCAI, ACC, and HRS have published a joint document providing recommendations for the establishment and maintenance of left atrial appendage occlusion programmes performing LAA closure.

Enrolment completed in randomised trial of MiStent and Xience

Stentys has announced that patient enrolment in its DESSOLVE III study, which is comparing the MiStent sirolimus-eluting stent with the Xience everolimus-eluting stent, has been completed.

Antonio Colombo joins Scientific Advisory Council of Miracor Medical Systems

Antonio Colombo (Cardiac Catheterization Laboratory, EMO GVM Centro Cuore Columbus; San Raffaele Hospital, Milan, Italy) has been appointed as a member of the Scientific Advisory Council of Miracor Medical Systems.

Survey suggests that cardiology is one of the rudest specialties

Victoria Bradley and others report that cardiology is among the departments/specialists seen as most likely to engage in rude, dismissive and aggressive behaviour towards colleagues.

Promising results for novel wave membrane blood pump

CorWave has reported promising early results for its left ventricle assist device (LVAD). The results were presented at 10th European Mechanical Circulatory Support meeting (EUMS; 2-5 December, Paris, France).

BioVentrix Announces first interventional heart failure procedure for left ventricle volume...

The first implantation of BioVentrix' micro-anchor technology entirely within the left ventricle using a catheter-based endovascular approach has been successfully completed.

Medinol US Commercialises Novel Coronary Stent

Medinol continued its introduction of its novel stent solutions during the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco.

Happiness has no direct effect on mortality

A study of a million UK women has shown that the common belief that happiness and stress directly cause ill health has been fuelled by the confusion of cause and effect in previous studies.

Interventional cardiologists may have “a false sense of security” about radiation...

Michael Seymour, director of Advocacy Programs for ORSIF, believes that there needs to be greater awareness of the dangers of radiation exposure during interventional procedures as some interventional cardiologists may not appreciate the true risks that they face in the cath lab.

Aortic stenosis: Future is Now!

Olcay Aksoy discusses how transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of patients with aortic stenosis.

Arterys partners with GE Healthcare to launch new cardiac imaging platform

The Arterys system is an intelligence platform designed to enhance standard medical imaging by enabling clinical visualisation and accurate quantification of blood flow inside the body.

Previous guidelines were “overconfident” about benefits of P2Y12 inhibitor pre-treatment

New European Society of Cardiology (ESC) guidelines for the management of patients who present with non-ST-segment elevation acute coronary syndrome were revealed at the 2015 ESC Congress (29 August-2 September, London, UK) and simultaneously published in European Heart Journal. The chairperson of the guidelines Marco Roffi (Interventional Cardiology Unit, University Hospital, Geneva, Switzerland) outlines the main differences between these guidelines and previous guidelines.

New European code says no to direct sponsorship of physicians to...

The European Diagnostics Manufacturers Association and the European Medical Technology Industry have approved a new joint code of conduct that stipulates that, after 31 December 2017, industry should no longer provide direct "financial or in kind support" to individual healthcare professionals to cover the costs of them attending third-party medical conferences.

First patient enrolled in Mitralign’s US percutaneous tricuspid repair study

The first US patient has been enrolled in Mitralign's SCOUT study, which is evaluating the company's percutaneous tricuspid valve annuloplasty system (Trialign).

MedStar Heart and Vascular Institute at MedStar Washington Hospital Center to...

The FDA has given IDE approval to MedStar Heart and Vascular Institute at MedStar Washington Hospital Center (Washington, DC, USA) to start a new study of TAVI in low-risk patients.

Heartbeat International foundation and Biotronik open new centre in the Dominican...

The Heartbeat International foundation and Biotronik have opened a new heart centre in the Dominican capital of Santo Domingo. At the centre, patients will be able to received donated pacemakers and defibrillators.

Personally tailored diabetes care reduces mortality in women but not men

This structured approach could conflict with men's tendency to trust self-directed learning instead of self-management, say study authors.

New delivery sheath may enable more patients to undergo transfemoral TAVI

Walid K Abu Shaleh and others report in Catheterization and Cardiovascular Interventions that a new balloon-expandable, re-collapsible (BERC) sheath may "considerably expand" the population suitable for TAVI via the transfemoral approach.

The rewards of revascularising a CTO

J Aaron Grantham describes the effect of using PCI to treat a patient with a CTO of the left anterior descending coronary artery.

Helping Little Hearts to mend

Nurun Nahar Fatema talks about how Muntada Aid's Little Hearts campaign has helped children in Bangladesh with congenital heart problems.

Medical titles are “hierarchical” and “hardly appropriate” for person-centred care

In a comment piece in the British Medical Journal, Ashley Graham Kennedy argues that title "doctor" is hierarchical because it suggests that a patient is lesser than and, should defer to, a physician.

First patient undergoes mitral replacement with NaviGate Cardiac Structures’ mitral valve...

NaviGate Cardiac Structures has revealed that the first-in-human implant of its catheter-guided, mitral-valve stent into a beating heart was performed successfully in a 53-year-old male patient presenting with severe mitral regurgitation.

Sedentary patients with heart disease have worse health even if they...

Patients with heart disease who sit a lot have significantly worse body mass index and cardiorespiratory fitness, even if they exercise.

Vascular Solutions’ R350 guidewire receives 510(k) clearance

The new R350 uses a nitinol core, designed to provide superior flexibility and kink-resistance in extreme tortuosity, and a hydrophilic coating on the distal 200cm.

i-cor synchronised cardiac assist system recieves CE mark

The product by Xenios AG can now be sold in Europe as the world's first heartbeat-synchronised cardiac assist for cardiogenic shock and high-risk interventions.

Biosense Webster acquires Coherex Medical

Biosense Webster has announced that it has acquired Coherex Medical, developers of the Coherex WaveCrest left atrial appendage (LAA) occlusion system. "The Coherex WaveCrest System...

FDA issues safety communication on lubricious coating separation from intravascular medical...

The communication includes guidelines for healthcare providers treating patients during or after intravascular procedures.

Occurrence of surgical ‘never events’ unrelated to hospital performance

A study has found that the size of individual hospitals is the only factor influencing their rate of 'never events'.

Next-generation Watchman approved for use in Europe

The next-generation Watchman left atrial appendage closure device (Watchman FLX) has received CE mark approval and the first implants of the device have taken place in Europe, commencing limited market release.

Anticoagulation with heparin “should remain standard of care” during TAVI procedures

George Dangas (New York, USA) and others that heparin should continue to be the first-line anticoagulant for TAVI procedures because it is not associated with a significantly increased risk of bleeding compared with bivalirudin.

Thrombus aspiration does not improve 12-month outcomes according to TATORT-NSTEMI trial

TATORT-NSTEMI is the first randomised trial investigating the impact of thrombectomy before percutaneous coronary intervention.

American Heart Association and Google Life Sciences to collaborate on US$50...

The AHA and GLS will invest US$25 million each over roughly five years to support a research collaboration targeting coronary heart disease and its consequences.

Moderate coffee consumption may be good for you

According to a study published in Circulation, people who regularly drink moderate amounts of coffee daily (less than five cups per day) have a lower risk of deaths from cardiovascular disease.

Cardiovascular Systems CEO to take medical leave

David L Martin, chief executive officer of Cardiovascular Systems is due to take approximately three months to focus on treatment for cancer.

Enrolment begins in the ACIST-FFR multi-centre study

The purpose of the ACIST-FFR study is to advance clinical understandings of FFR technologies. It will investigate measurement accuracy, incidence of drift and device success.

COURAGE: No long-term benefit with PCI in stable disease

Steven P Sedlis and others that 15-year follow-up data from COURAGE indicate that PCI does not significantly improve survival compared with optimal medical therapy in patients with stable coronary artery disease.

SentreHeart to present data on Lariat treatment for atrial fibrillation at...

The research is intended to demonstrate that a Lariat procedure for LAA closure, plus a subsequent PVI catheter ablation, will lead to a reduced incidence of recurrent AFib compared to PVI alone.

New risk score could aid decision making about extending dual antiplatelet...

Robert W Yeh (Boston, USA) told delegates at the 2015 AHA scientific sessions that a new risk score could be used to predict which patients may benefit from extending dual antiplatelet therapy beyond 12 months.

Fewer “inappropriate” PCI procedures are being performed in the USA

A new study indicates that following the introduction of appropriate use criteria for coronary revascularisation, there has been a significant reduction in number of inappropriate PCI procedures that are performed in the USA.

Study shows extended-release aspirin capsules can deliver sustained antiplatelet effects for...

The New Haven Pharmaceuticals study analysed the effects of the company's "Durlaza" extended-release aspirin.

New transcatheter heart valve manufacturing facility certified for JenaValve

The wholly-owned facility is equipped to develop, test and deliver existing and improving valve technologies

Discussion on the DAPT score

In this ACC/MedPage Today video, Peter Block and Robert Yeh discuss the DAPT score, which Yeh presented at the 2015 AHA scientific sessions.

An interventional cardiologist’s view on left atrial appendage closure

Martin W Bergmann is an interventional cardiologist working in Germany, who performs percutaneous LAA closure procedures. He explores why there is still a need for such procedures even in the era of novel oral anticoagulants.

Protein reprogramming method might yield rich source of heart cells for...

A study has reported an efficient protein-based method for converting fibroblasts into cardiac progenitor cells (CPCs) directly.

WomenHeart appoints three new members to its board of directors

WomenHeart: The National Coalition for Women with Heart Disease has appointed three women heart disease survivors.

PEGASUS-TIMI 54 subanalysis provides additional insights into long-term ticagrelor use

The PEGASUS-TIMI 54 subanalysis evaluated reasons and rates for discontinuation of ticagrelor in patients who had experienced a myocardial infarction one to three years prior to study randomisation, and the efficacy in those patients who stayed on therapy.

3D system may more accurately identify best donor hearts for a...

Researchers have created a novel library of healthy children's 3D reconstructed hearts using MRI and CT images.

Women cardiologists specialise in different areas, and are paid less, than...

Over a lifetime of work, women cardiologists earn more than US$1 million less than their male counterparts.

North Carolina scientist awarded American Heart Association Population Research Prize

The prize was in recognition of his findings of artery wall predictors of cardiovascular disease risk.

New long-term data demonstrates benefit of CardioMEMS HF system over standard...

Patients from the study's control group had a 48% reduction in HF hospitalisations after moving from standard HF therapy to the CardioMEMS HF System.

Group therapy can promote cardiovascular health, according to study

Peer group support has been found to improve healthy behaviour in people with cardiovascular risk factors.

Wealthiest patients may have edge over sickest in organ transplants

The ability to register with more than one organ transplant centre seems to increase a patient's likelihood of receiving a transplant.

Xeltis completes second feasibility clinical trial on bioabsorbable cardiovascular technology

The trial has shown positive results in patients a year after surgery for Xeltis' products.

EMA grants CardioCel a broader indication for use in Europe

The product is now approved for use in the repair and construction of heart valves.

World’s largest cardiovascular imaging conference to showcase technological innovations

Innovations in echocardiography, cardiovascular magnetic resonance (CMR), nuclear cardiology and cardiac computed tomography (CT) will be presented and discussed during the meeting.

TherOx granted FDA IDE Approval to study next-generation supersaturated oxygen therapy...

This study-which will recruit 100 patients-is taking place to support a pre-market approval (PMA) application to the FDA.

Third-generation renal denervation system by ReDy receives CE mark approval

Based on a novel multi-ablation technology, ReDy claim that its renal denervation system delivers a pre-determined RF ablation with a single positioning.

MC3 Cardiopulmonary acquires surgical cannula product assets from Terumo Cardiovascular Systems

The company has built a 60,000-square-foot manufacturing facility in Dexter, USA, to bring the Sarns Soft-Flow arterial cannula back to market in 2016.

New data on The Medicines Company’s cardiovascular portfolio to be presented...

The company has announced it will present late breaking clinical trial data on ALN-PCSsc, as well as three abstracts on the antithrombotic cangrelor (Kangreal).

Minimally invasive, leadless endovascular neuromodulation system introduced by Enopace Biomedical

The Harmony catheter-based neurostimulator device system is designed to treat congestive heart failure.

Custom-designed vascular training model now available at events

The ThinkRadial Vascular Training Model provides realistic simulation to several procedurally critical vascular destinations, while allowing the practitioner to "see" the way radial products perform inside the body.

Medeon Biodesign’s XPro large bore vascular closure device achieves successful first-in-man...

The device's percutaneous approach is designed to be less traumatic for patients and to achieve shorter recovery times.

CardioCel bio-scaffold launched and sold in Malaysia

The launch is one stage of Admedus' ongoing global rollout of Cardiocel, which has now been implanted in over 3,000 patients.

American College of Physicians joins brief urging Supreme Court to uphold...

The petitioners argue that health disparities continue along the lines of race and ethnicity, and that health profession needs to be culturally competent.

Low baseline albumin associated with increased all-cause mortality after TAVI

A new study indicates that low baseline albumin (_4g/dl) in patients undergoing TAVI is associated with a four-fold increase in all-cause mortality at one year and a two-fold increase in all-cause mortality at two years.

Tryton Medical files pre-market approval application with US FDA for Tryton...

The stent could become the first bifurcation stent available in the USA if approved.

SCAI calls for abstract submissions

Roxana Mehran encourages people to attend the 2016 Society for Cardiac Angiography and Interventions meeting

The risk of stroke in patients undergoing TAVI

While TAVI is the standard of care for inoperable patients with severe symptomatic aortic stenosis and a compelling approved alternative to surgical aortic valve replacement for patients at high operative risk, the early experience with the intervention raised concerns regarding the risk of stroke and other neurological events. Alexandra Lansky and Cody Pietras explore the risk of stroke in patients undergoing TAVI.

PiCSO highlighted at TCT as novel therapy

Miracor Medical Systems have reported that, during this year's TCT meeting, PiCSO has been highlighted in several sessions as offering new hope for cardioprotection during percutaneous coronary intervention.

Opsens performs 1,000th procedure with the OptoWire

Opsens has also begun pre-commercialisation activities for its Fractional Flow Reserve products.

Death after heart surgery overwhelmingly determined by patient risk factors

A study published in Anaesthesia has shown that death after heart surgery is not determined by which professionals or hospitals provide the care.

Direct Flow Medical appoints new co-principal investigator for US SALUS pivotal...

Direct Flow Medical has appointed D Scott Lim as national co-principal investigator for the SALUS pivotal trial. He joins co-principal investigator Isaac George.

In-hospital mortality higher for young women after STEMI

Young women with ST-elevation myocardial infarction spent more days in hospital, had higher rates of in-hospital mortality and were less likely to receive angioplasties and stenting than men, according to a study published in the Journal of the American College of Cardiology (JACC).

Angioplasty balloon catheter from AV Medical Technologies receives FDA clearance

AV Medical Technologies has announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Chameleon angioplasty balloon catheter.

Biotronik announces European launch of new generation of Galeo coronary guide...

A press release from Biotronik has announced the European market launch of a new range of Galeo guide coronary workhorse guide wires, inspired by the original Galeo design.

Curbing atherosclerosis and precision medicine should be main strategies to transform...

According to research presented at the Canadian Cardiovascular Congress (CCC) by Jean-Claude Tardif, personalised therapy should become a main strategy in the treatment and prevention of heart disease and stroke.

Edwards Lifesciences appoints Martha Marsh to board of directors

Edwards Lifesciences has announced that Martha H Marsh has been appointed to its board of directors. Currently, Marsh serves on the boards of directors of AMN Healthcare Services and Owens & Minor.

New guidance issued for multivessel PCI, thrombectomy in heart attack patients

A focused update has been issued offering new guidelines on the use of multivessel coronary interventions and thrombectomy in patients with heart attacks due to completely blocked arteries, from American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions, in collaboration with the American College of Emergency Physicians.

Spiral Flow PV bypass graft launched by Vascular Flow Technologies

The graft was launched at the 31st annual Deutschen Gesellschaft fÌ_r GefÌ_ÌÙmedezin (DGG) in MÌ_nster, Germany. Earlier this month, it was implanted in a live case during the Vascular/Endovascular Masterclass in Hamburg, Germany.

Further evidence needed for clinical consequences of reduced leaflet motion

A new study indicates that reduced leaflet motion occurs with all types of bioprosthetic valves and may be linked to an increased risk of stroke. Therefore, the study investigators state that further studies are needed to better characterise the clinical consequences of reduced leaflet motion.

Antiplatelet therapy with blood thinners reduces mortality for angioplasty patients

Glycoprotein 2c/3a inhibitor (GPI) use in patients following angioplasty procedures has been associated with a reduced risk of all-cause in-hospital mortality, but an increased risk of bleeding.

Corrado Tamburino

Corrado Tamburino (full professor of Cardiology, Ferrarotto & Policlinico Hospitals, University of Catania, Catania, Italy), and a course director for PCR London Valves has done extensive work in developing PCI techniques for left main disease

Use of fusion imaging during TAVI

Mehdi Eskandari and Mark Monaghan explore the use of TOE and fluoroscopy during TAVI, focusing on how fusion imaging may help to improve safety and accuracy during these procedures.

British Heart Foundation announces strategy for over half a billion pounds...

The British Heart Foundation (BHF) has launched a five-year strategy for research, including a commitment to sustain funding for the best researchers across all areas of cardiovascular disease (CD).

One-year outcomes from OrbusNeich’s Combo REMEDEE all-comers registry demonstrate clinical effectiveness...

REMEDEE is a 1000-patient registry designed to evaluate the Combo Dual Therapy Stent for the treatment of coronary lesions in the routine clinical care setting. The outcomes demonstrate clinical effectiveness in one-year target lesion failure.

Neovasc Tiara featured in live case broadcast at TCT 2015 meeting

In the broadcast to the main arena of the conference, a 35mm Tiara transcatheter mitral valve was successfully implanted in a patient with severe mitral regurgitation within thirty minutes, with no procedural complications.

Edwards Sapien 3 valve demonstrates high survival and low stroke rate...

Edwards Lifesciences has announced a one-year survival rate of 89.3% for high-risk patients who received the Edwards Sapien 3 transcatheter aortic valve via transfemoral, as well as low rates of paravalvular leak and stroke.

SHIELD I trial results confirm consistent cardiac support offered by St....

The data show that the hemodynamics of severely ill patients undergoing complex revascularisation procedures can be maintaimed by use of the HeartMate PHP cardiac assist.

Lesion preparation with scoring balloon may improve performance of drug-coated balloons...

ISAR-DESIRE 4, which is the first trial to examine the role of lesion preparation before using drug-coated balloons, indicates that the use of a scoring balloon may enhance the efficacy of drug-coated balloons to treat in-stent restenosis.

Edwards Sapien XT valve granted FDA approval for aortic valve-in-valve procedures

Edwards Lifesciences has announced US FDA approval has been granted for aortic valve-in-valve procedures using its Sapien XT transcatheter heart valve. This follows the presentation of high survival and low stroke rates from the one-year outcomes of the PARTNER II Valve-in-Valve Study.

Sentinel cerebral protection system provides definite cognitive benefit for TAVI patients

Results from the MISTRAL-C study indicate that use of the Sentinel cerebral protection system (Claret Medical) during TAVI procedures is associated with definitive cognitive benefit. The data were presented at TCT.

“Excellent” one-year outcomes for Direct Medical TAVI valve

press release reports that one-year data from the DISCOVER post-market study that demonstrate excellent real-world results for the Direct Flow Medical TAVI valve.

Desolve bioresorbable scaffold continues to show low MACE rate at three...

Three-year data for Elixir Medical's Desolve novolimus-eluting bioresorbable scaffold indicate that the device is associated with a low overall major adverse cardiac events rate and sustained lumen gain.

European DISCHARGE trial will analyse whether CT can replace cardiac catheterisation...

A DISCHARGE study currently examines whether CT or ICA are preferable for which patients with suspected coronary artery disease based on stable chest pain. The major goal of the trial is to determine whether CT helps to reduce myocardial infarction, stroke, and cardiovascular death.

Long-term results of RESPECT indicate that PFO closure may be effective...

The long-term study results from the RESPECT trial found that closing a patent foramen ovale (PFO) with an Amplatzer PFO Occluder was superior to medical management in the prevention of recurrent cryptogenic stroke in patients who previously had a cryptogenic stroke.

ABSORB III data reviewed

In this American College of Cardiology video, Peter Block and Dean Kereiakes discuss the results and implications of the ABSORB III study that was presented, by Kereiakes, at TCT 2015.

Medtronic CoreValve System ‘real-world’ US patient experience data replicates clinical outcomes

Medtronic has released the first outcomes data for its CoreValve Transcatheter Aortic Valve Replacement (TAVR) System using CoreValve data from The Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The everyday clinical experience of 6,160 patients has been shown to replicate the outcomes achieved in clinical trials.

Corindus Vascular Robotics and Mayo Clinic Launch Vascular Robotic Program to...

Corindus Vascular Robotics has announced the formation of a joint robotic-assisted percutaneous coronary intervention (PCI) research and clinical program. This program utilises Corindus' CorPath System whilst protecting hospital employees from occupational radiation exposure and orthopedic stress and strain.

Stentys sirolimus-eluting stent confirms best-in-class performance at three years

Stentys has announced that the long-term performance of the siromilus-eluting Self-Apposing stent has been confirmed by three-year follow-up imaging data from the Stentys arm of the APPOSITION IV clinical. The data was presented by Robert-Jan van Geuns from Erasmus Medical Center in Rotterdam at TCT 2015.

Medtronic CoreValve Evolut R System demonstrates strong performance of recapturable and...

Medtronic have announced new one-year data revealing exceptional clinical outcomes for transcatheter aortic valve replacement (TAVR) with their CoreValve Evolut R System. This system is the first and only next-generation recapturable, self-expanding valve available in the US market.

HeartFlow FFRCT Analysis can lower cost of care by up to...

FFRCT Analysis technology from HeartFlow could lower the cost of evaluating patients with suspected coronary artery disease by as much as 32%, when compared to invasive coronary angiography. New data reveals the potential to use the technology to improve patient quality of life.

Medtronic CoreValve System shows low mortality and improved quality of life...

Medtronic have presented new clinical data that shows positive clinical outcomes at one year for the CoreValve System in new populations including patients with a degenerated surgical bioprosthesis, end-stage renal disease and patients with low gradient aortic stenosis. Results from the three populations evaluated within the CoreValve US Expanded Use Study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium.

LIVE from TCT: No evidence of scaffold thrombosis with Biotronik’s magnesium...

According to results presented at TCT yesterday, the BIOSOLVE II study met is primary angiographic endpoint. Furthermore, the results also showed that there was no evidence of scaffold thrombosis with Biotronik's magnesium scaffold.

LIVE from TCT: Acceptable acute safety profile of Tryton side-branch stent...

According to Tryton Medical, results from the Tryton Confirmatory Study confirm the acceptable acute safety profile of the Tryton side-branch stent for the treatment of coronary bifurcation lesions in vessels appropriate for a _2.5mm stent.

LIVE from TCT: Ranolazine does not reduce adverse events in patients...

The RIVER-PCI study, which was presented at TCT today, shows that ranolazine did not reduce the composite rate of ischemia-driven revascularisation or hospitalisation in patients with a history of chronic angina who had residual un-revascularised coronary artery disease after PCI.

LIVE from TCT: Promising results for novel drug-filled stent

Initial results, presented at TCT, from the Revelution trial indicate that Medtronic's drug-filled stent is associated with early vessel healing and controlled polymer-free drug elution.

Lariat surgical delivery device receives the CE mark

SentreHeart has received the CE Mark approval for its Lariat surgical left atrial appendage suture delivery device. The suture-based solution is designed for soft tissue closure, including the left atrial appendage closure.

Gary Lickovitch becomes vice president of sales and service at Corindus...

Corindus Vascular Robotics has announced that it has named Gary Lickovitch as vice president of sales and service. He will report directly to Corindus' president and chief executive officer, David Handler.

Boston Scientific to present data for wide range of products at...

Key data presentations spanning Boston Scientific's broad interventional cardiology, structural heart and peripheral interventions portfolios will be shared at the TCT meeting (10-15 October, San Francisco, USA), the company has revealed.

Elixir will stream its first live case transmission of Desolve at...

Elixir Medical has announced that it will stream the first live transmission case demonstration of its Desolve Cx novolimus-eluting bioresorbable coronary scaffold system at TCT (11-15 October, San Francisco, USA).

Medtronic to unveil new clinical data at TCT

Medtronic has announced a preview of notable clinical studies that will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium (11-15 October, San Francisco, USA). The two-year results from the pivotal IN.PACT SFA clinical trial will be unveiled in a First Report Investigation presentation.

Cardinal Health completes acquisition of Cordis

Cardinal Health has announced that it has completed the acquisition of Johnson & Johnson’s Cordis business for $1.944 billion. Planning has been ongoing since the acquisition announcement in early March 2015, and the integration is off to a successful start with management teams in place worldwide.

Boston Scientific announces additional investment and right to acquire MValve Technologies

Boston Scientific has announced that it has closed on an additional round of financing with MValve Technologies, a developer of a percutaneous mitral valve replacement system, designed to work with the Boston Scientific Lotus valve.

New test could identify two-thirds of patients at very low risk...

Using a high sensitivity blood test, researchers have identified the optimal level of a protein called troponin that could rule out a diagnosis of heart attack for two-thirds of people attending the emergency department, according to new research.

Robotic PCI can now be used for radial access procedures in...

The FDA has given 510(k) clearance to Corindus Vascular Robotics for its robotic-assisted CorPath System to be used during percutaneous coronary intervention (PCI) performed via radial access. The 510(k) clearance was based on results of a clinical trial, with an enrolment of 30 patients, that demonstrated 100% device and clinical success.

New randomised trial will compare sutureless valve to standard bioprostheses

Sorin has announced the initiation of PERSIST, which is the first international, prospective, post-market randomised multicentre trial evaluating the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease.

Positive preclinical data for trileaflet repair with CardioCel presented at EACTS

According to preclinical data presented at EACTS (3-7 October, Amsterdam, the Netherlands), CardioCel can be successfully used to perform trileaflet repair in a sheep model with no or minimal calcification detected.

Medtronic completes acquisition of Twelve

Medtronic has completed its acquisition of Twelve, which is a privately-held medical device company that is focused on the development of a transcatheter mitral valve implantation device. Medtronic says it looks forward to welcoming the Twelve team.

FDA issues notification about reduced leaflet motion with bioprosthetic aortic valves

The FDA has announced it is working with ACC, STS, and device manufacturers to design clinical studies to fully evaluate reduced leaflet motion for all types of bioprosthetic aortic valves. However, it says it believes such devices are reasonably safe and effective when used according to their FDA-approved indications.

Further studies needed to find effective treatment for reperfusion injury

In this commentary, Michael Gibson reviews the various approaches that have been evaluated for reperfusion injury and states why he believes further studies in this area are still needed.

50th patent for HeartFlow secured

The United States Patent and Trademark Office has issued to HeartFlow its 50th patent. The patent, "Method and System for Patient-Specific Modeling of Blood Flow" (US Patent No. 9,152,757), continues the expansion of companyt's patent portfolio based on its non-invasive HeartFlow FFRCT analysis.

First-in-man implant of MValve Technologies’ transcaheter mitral valve replacement system

MValve Technologies has revealed that the first human implantation of its catheter-based transapical mitral valve replacement system has taken place. The procedure was completed successfully at the University Clinic in Bonn, Germany.

First cohort of patients enrolled in FANTOM II clinical trial

The first cohort of 110 patients has been enrolled in the FANTOM II clinical trial. Reva Medical hopes to use the data, when available, from the study when it applies for the CE mark for its Fantom sirolimus-eluting bioresorbable scaffold.

Post-hoc analysis of Tryton side-branch stent trial published

A post-hoc analysis of the Tryton randomised controlled trial, now published in Catheterization and Cardiovascular Interventions, show that the Tryton side-branch stent is associated with reduced target vessel failure and improved side branch percent diameter stenosis in patients with vessels _2.25mm in diameter.

Venair collaborates on leading research project with Georgia Institute of Technology

Venair provides mold building and casting with silicone for physical model of left ventricle required for Georgia Institute's research. The mold built by Venair assists physical understanding of heart diseases and conditions.

Biosensors to commercialise BMX-J drug-eluting stent system in Japan

BMX-J is an original equipment manufacturer version of the Nobori drug-eluting stent, which consists of Biosensors’ unique drug-eluting stent that incorporates a biodegradable polymer and the company’s proprietary drug Biolimus A9.

St Jude Medical collaborates with Mended Little Hearts to produce The...

St Jude Medical and Mended Little Hearts have joined together to create The Mended Little HeartGuide-a comprehensive digital guidebook for parents and families of children with congenital heart conditions.

Myocardial injury after TAVI: What matters; what doesn’t?

CardioSource WorldNews talks to Lars Svensson about the clinical and functional outcomes of injuries to the myocardium after TAVI. The interview was conducted at ESC 2015.

World Heart Day focuses women’s heart health

Today is World Heart Day (29 September), which is organised by the World Heart Federation and aims to raise awareness of heart disease through education, advocacy and research, focuses on women's heart health. The British Heart Foundation reports women often wait longer than men before calling an ambulance after experiencing symptoms of a heart attack.

Occlutech receives the CE mark for its ventricle septal defect closure...

Occlutech now has CE mark approval for its muscular ventricle septal defect closure device-is a specifically designed implant indicated for the minimally invasive closure of muscular ventricle septal defects.

Primary endpoint met in HeartMate 3 CE mark trial

Thoratec has announced that the HeartMate 3 trial, which evaluated the HeartMate 3 left ventricular assist device, has met its primary endpoint-a comparison of six month survival to a performance goal derived from the INTERMACS registry.

RenalGuard significantly reduces acute kidney injury during TAVI

According to the results of PROTECT-TAVI, the use of RenalGuard during transcatheter aortic valve implantation (TAVI) procedures is associated with a significant reduction in in post-procedural acute kidney injury compared with standard treatment.

CE mark for new TAVI simulation software

FEops has received the CE mark for its transcatheter aortic valve implantation (TAVI) simulation software. The TAVIguide technology is designed to revolutionise preoperative planning for TAVI by providing insights into the interaction between a patient's native aortic root and the aortic valve.

More than 1000 patients have now been treated with Acurate Neo...

Symetis has announced, in less than a year after the device was commercially launched, the Acurate neo/TF has been implanted in more than 1,000 patients. The company's other valve, Acurate TA system, has achieved a number two position in its segment of the European TAVI market.

Medinol completes enrolment of its multicentre trial of eDES

Medinol has announced that enrolment in its BIONICS trial, a global, prospective, randomised, multicentre, clinical trial designed to evaluate the safety and effectiveness of a new coronary stent system (eDES), has been completed.

CeloNova announces FDA approval to start a Cobra PzF coronary stent...

This is a second major interventional cardiology trial for CeloNova in the USA, following the successful enrolment of the PzF SHIELD clinical trial earlier this year.

Miracor launches PiCSO impulse system in Asia

Miracor has announced the first treatments of patients with the PiCSO impulse system in the United Arab Emirates (UAE), marking the launch of this novel therapy in Asia in cooperation with Medical Technology.

CE mark for 27mm and 29mm of Portico TAVI valves

St Jude Medical has received the CE mark for its 27mm and 29mm Portico TAVI valves. The company says that it is now able to offer a full portfolio of Portico sizing options for physicians treating patients with aortic stenosis.

First-in-man cases with Mitra-Space presented

Cardiosolutions unveiled the first-in-human experience with its Mitra-Spacer system at PCR London Valves (20-22 September, Berlin, Germany). The novel system is intended to treat or bridge heart failure patients whose operative mortality risk for undergoing conventional open-heart surgery is deemed too high.

High definition IVUS used for the first time

Following the market release of the ACIST HDi intravascular ultrasound (IVUS), Scripps Clinic (La Jolla, USA) has become the first Cardiac Cath Lab in the world to use the new system. The system was used to optimise stent sizing and ensure proper stent expansion.

Open-label phase 1 study to evaluate off-the-shelf, biomaterial scaffold

Ventrix has initiated a phase 1, open-label study of its off-the-shelf, biomaterial scaffold (VentriGel). The scaffold is designed to facilitate the repair of cardiac tissue following myocardial infarction.

Incoming St Jude Medical president and chief executive officer announces executive...

St Jude Medical has announced the new executive leadership team that incoming president and chief executive officer Michael T Rousseau has chosen to lead the organisation, effective from 1 January 2016.

First patient enrolled in CeloNova’s e-COBRA clinical registry

The French registry is evaluating the Cobra PzF coronary stent system in patients with heart disease.

Harpoon Medical enrols ten patients in Early Feasibility Study with 100%...

The company has also received US$1.4m of a US$2m bridge round to accelerate its clinical programme.

Direct transfer of STEMI patients to cath lab reduces mortality

Lindsay L Anderson and others report that directly transferring patients with STEMI from the referring hospital to the cath lab-rather other departments (such as the emergency department)-of the receiving hospital is associated with significant reductions in time to reperfusion and mortality.

Sorin and Cyberonics announce appointment of LivaNova’s chief financial officer

Vivid Sehgal’s appointment as chief financial officer of LivaNova will be effective with the closing of the proposed merger of Sorin and Cyberonics.

Admedus to present CardioCel data At European cardio-thoracic conference

Admedus will present CardioCel data for the complete repair of aortic heart valves at the 29th European Association for Cardio-Thoracic Surgery Annual Meeting (EACTS) (3-7 October, Amsterdam, the Netherlands).

Medicure announces filing of sNDA for new Aggrastat indication

The supplemental New Drug Application seeks the addition of ST segment elevation myocardial infarction indication for Aggrastat.

Nipro to acquire Infraredx

The acquisition, which is subject to certain conditions, is expected to close in October 2015.

The OPTIDUAL trial

For EHJ today, Karl Swedberg moderates a discussion between Gerard Helft and Lars Wallentin about the OPTIDUAL study (which Helft presented at the ESC).

Rediscovering the transfemoral approach for structural heart interventions

Before we abandon "the good old femoral route" completely, the advent of structural heart disease interventions means that we still have a use for the approach. Flavio Ribichini explores the use of the transfemoral approach with these interventions.

Philips and Catharina Hospital sign technology agreement for largest cardiovascular centre...

More patients with complex cardiovascular diseases will soon be able to benefit from the latest facilities in the field of image-guided minimally invasive treatments at Catharina Hospital.

Analysis projects Carillon Mitral Contour System as a cost effective option...

Researchers analysed data derived from the TITAN clinical trial, which demonstrated significant clinical merits of the Carillon technology, and developed a comprehensive cost-effectiveness model that projects the costs of the technology and compares them to the benefits.

Thoratec announces start of SHIELD II US clinical trial

The SHIELD II US clinical trial will examine the use of the HeartMate PHP in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure.

FDA approves expanded Brilinta indication to include long-term use in patients...

The US Food and Drug Administration (FDA) has approved AstraZenca's Brilinta (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year.

Absorb is non-inferior to Xience in ABSORB-Japan

Results from the ABSORB-Japan study, which were presented at the 2015 European Society of Cardiology meeting, indicate that the bioresorbable vascular scaffold (Absorb, Abbott Vascular) is non-inferior to an everolimus-eluting stent with a permanent polymer (Xience, Abbott Vascular).

First patient enrolled in BIOFLOW-VI clinical study in China

The first patient has been enrolled in the BIOFLOW-VI clinical study in China. The aim of the study is further demonstrate the safety and efficacy of a hybrid drug-eluting stent (Orsiro, Biotronik) and support Chinese market approval.

Mitralign given the OK for early feasibility study of its percutaneous...

The FDA has granted Mitralign investigational device exemption approval for the company to conduct an early feasibility study to examine its percutaneous tricuspid valve annuloplasty system. The SCOUT Study will take place in select centres in the USA.

Data show benefits of cangrelor in patients undergoing either radial or...

New data indicate that the intravenous antiplatelet agent cangrelor (Kengreal, The Medicines Company) is associated with significant reduction in ischaemic events compared with clopidogrel in patients undergoing PCI with either the femoral or the radial approach.

Javier Escaned

Javier Escaned (head of Section, Interventional Cardiology Unit, Hospital Clinico San Carlos, Madrid, Spain) is a co-course director of EuroPCR (17-20 May, Paris, France).

FFRCT significantly reduces the number of invasive tests with no sign...

The PLATFORM study, which was presented at the ESC, indicates that use of FFRCT is associated with a significant reduction in the number of invasive tests that do not find evidence of obstructive coronary artery disease.

HeartWare International to acquire Valtech Cardio

Valtech Cardio specialises in the development of innovative surgical and transcatheter valve repair and replacement devices for the treatment of mitral valve regurgitation and tricuspid valve regurgitation.

LIVE from the ESC: Five-year FAME data further confirms benefits of...

The five-year results of the FAME study, which were presented at the ESC yesterday, have confirmed that FFR-guided PCI has sustained, long-term benefits compared with angiography. They show that FFR-guided PCI can contribute to reductions in all-cause mortality, cardiac mortality and an overall use of healthcare resources.

LIVE from ESC: No benefit with aldosterone antagonists in acute myocardial...

In the ALBATROSS study, which was presented at the ESC Congress this morning, adding aldosterone to standard therapy in patients with acute myocardial infarction was not associated with a significant reduction in the primary outcome (which included death, resuscitated cardiac arrest, and significant ventricular arrhythmia)

Philips to showcase integrated cardiology solutions ESC Congress 2015

Royal Philips has announced its presence at ESC Congress 2015, where the company is showcasing its latest cardiology solutions, including Heart ModelA.I., EchoNavigator and IntelliSpace Cardiovascular

Risk of all-cause mortality with post-discharge bleeding after PCI is greater...

Philippe G̩n̩reux and others report in the Journal of the American College of Cardiology that data from ADAPT-DES indicate that the risk of all-cause mortality that is associated with post-discharge bleeding after PCI is 2.6-fold greater than the risk of all-cause mortality that is associated with post-discharge myocardial infarction.

FDA approval for evolocumab

The FDA has approved evolocumab (Repatha, Amgen), which is a new cholesterol-lowering medication that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9)-a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C).

Benefits and challenges of secondary prevention after myocardial infarction

This European Society of Cardiology (ESC) video explores the role of comprehensive rehabilitation programmes for the secondary prevention of myocardial infarction.

ESC “very excited” to be in London

The president of the ESC, Fausto Pinto, claims that the society is "very excited" to be holding its annual congress in London (UK) this week, stating that the city "has a fantastic reputation for welcoming people from all around the world from international sporting competitions to ground-breaking educational and medical conferences."

The Medicines Company announces participation at 2015 European Society of Cardiology...

The Medicines Company will present results of recent clinical studies from its cardiovascular product portfolio at the 2015 European Society of Cardiology (ESC) Congress (29 August-2 September, London, UK).

Direct Flow Medical appoints Mary Edwards as vice president of regulatory...

Edwards will oversee all global clinical and regulatory efforts including the company's US SALUS pivotal trial studying the Direct Flow Medical Transcatheter Aortic Valve System, as well as the DISCOVER post-market European study.

SentreHEART elects Richard Ferrari to board of directors

Ferrari is currently the managing director and co-founder of De Novo Ventures and brings a wealth of strategic and operational knowledge SentreHEART's board.

Colibri Heart Valve receives patent for controlled release of percutaneous heart...

Colibri Heart Valve has received an issue notification from the US Patent and Trademark Office regarding the forthcoming granting of a US Patent titled, "Percutaneous replacement heart valve and a delivery and implantation system."

Medtronic to buy company that is developing a transcatheter mitral valve...

Medtronic has announced that it has signed a definitive agreement to acquire the company Twelve, which is focused on the development of a transcatheter mitral valve implantation (TMVI) device.

2015 TCT late-breaking trials announced

The Cardiovascular Research Foundation (CRF) has announced the late-breaking trials and first report investigations that will be presented at this years' Transcatheter Cardiovascular Therapeutics (TCT) 2015 scientific symposium.

Clinical trial launched to test if coronary stent patients can avoid...

The international clinical trial TWILIGHT will test the safety and effectiveness of treating coronary stent patients with the anti-clotting medication ticagrelor instead of combining it with aspirin.

Cyberonics and Sorin provide merger update

Cyberonics has set a date for a special meeting of its stockholders to consider and vote on the transaction and certain other related matters on 22 September.

“We all need the strength” to challenge unacceptable behaviour

The editors of Annals of Internal Medicine have called for doctors to confront colleagues who act in a disrespectful manner towards patients after an anonymous essay in the journal highlighted incidences in which unprofessional behaviour was condoned.

Heart attack patients without obstructive coronary artery disease are at high...

This is the first study to focus on the burden of residual angina after an initial heart attack and re-hospitalisations in patients without versus with obstructive coronary artery disease.

Corindus Vascular Robotics partners with Unfors RaySafe to help reduce radiation...

Corindus Vascular Robotics and Unfors RaySafe have announced a distribution agreement to allow Corindus to offer the RaySafe i2 real-time radiation dose monitoring system in conjunction with its CorPath system.

Bifurcation lesions: When a two-stent technique is needed

The advent of second-generation drug-eluting stents and the associated improved safety and efficacy has meant that the risks of using two stents for bifurcation lesions has significantly decreased. Maciej Lesiak explores when a two-stent strategy should be used.

Abiomed submits supplements to expand Impella 2.5 FDA pre-market approval

Abiomed has submitted US Food and Drug Administration pre-market approval supplemental submissions to expand Impella 2.5 pre-market approval to the entire Impella family of devices (Impella 2.5, Impella CP and Impella 5.0/LD).

US Endovascular and BrosMed enter into exclusive agreement to distribute coronary...

US Endovascular and BrosMed have entered into an exclusive agreement to distribute Artimes semi-compliant and Apollo non-compliant coronary angioplasty catheters.

Interventional cardiology devices market to be worth US$25.16bn by 2020

Increasing prevalence of cardiovascular diseases coupled with adoption of minimally invasive surgeries is expected to boost the interventional cardiology device market over the forecast period.

Medtronic issues recall for EnVeo R loading system

Medtronic has issued a Class 1 recall of its EnVeo R loading system following eight reports of the presence of particulates, which could potentially lead to blockages in the bloodstream.

A team approach to cardiac arrests after cardiac surgery

In this video for the Cardiothoracic Surgery Network, Jill Ley leads an expert panel discussion about managing patients with cardiac arrest after cardiac surgery. This video was filmed at the Society of Thoracic Surgeons' annual meeting.

Successful testosterone replacement therapy reduces the risk of cardiovascular events and...

A study indicates that normalisation of total testosterone levels with testosterone replacement therapy is associated with a significant reduction in the risk of myocardial infarction, stroke and all-cause mortality compared with non-normalisation with testosterone replacement therapy and no therapy in men with low testosterone.

FDA issues safety warning about left ventricular assist devices

The FDA has issued a safety alert telling healthcare professionals, patients, and carers about potential serious adverse effects with left ventricular assist devices. The alert relates to Thoratec's HeartMate II device and HeartWare' HVAD.

Tryton Medical completes enrolment in the Extended Access Registry for its...

The Tryton registry is designed to confirm the results from Tryton's pivotal Investigational Device Exemption (IDE) trial, and has successfully enrolled 133 patients from Europe and the USA.

Nitinol Devices & Components acquires Interface Catheter Solutions to create Confluent...

A press release says that the combined company will leverage the technical expertise of both NDC and Interface in highly precise and demanding medical devices.

Getting to grips with social media

Pascal Meier believes that social media is the logical next step from the internet-just as the internet has revolutionised connectivity, social media is revolutionising communication. In this commentary, he explains why social media presents a great opportunity for interventional cardiologists.

Bellerophon Therapeutics announces results from PRESERVATION I clinical trial for Bioabsorbable...

The results showed no statistically significant treatment differences between patients treated with the Bioabsorbable Cardiac Matrix and patients treated with placebo for both the primary and the secondary endpoints.

Abbott Vascular expands its structural heart portfolio with new mitral...

Abbott Vascular has announced it has entered into an agreement to purchase Tendyne Holdings (focused on developing minimally invasive mitral valve replacement therapies) and secured an option to purchase Cephea Valve Technologies (which is developing a catheter-based mitral valve replacement therapy).

Social media for interventional cardiologists: rewards and risks in daily practice

In this PCR video, Simon Walsh (UK) interviews Pascal Meier (Switzerland) about the potential of social media to contribute to overall education and knowledge of interventional cardiologists, and to actually improve the clinical management of patients as it facilitates the exchange of knowledge. However, the use of social media is not without risk.

CorPath system to be featured for the first time in Japan

In addition to allowing cardiologists to advance stents and guidewires with precision using digital controls, the system enables physicians to perform procedures while seated in a lead-lined interventional cockpit protected from radiation exposure.

First participants enrolled in dabigatran study of AF patients undergoing PCI

Boehringer Ingelheim has announced that the first US patients have been enrolled in its international clinical trial-RE-DUAL PCI, which is evaluating the efficacy and safety of dabigatran in patients with non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI).

Natec Medical receives FDA approval for Filao NC PTCA balloon catheter

Natec Medical has received 510k approval from US Food and Drug Administration (FDA) for its Filao NC PTCA balloon catheter, Natec's third device to obtain FDA approval.

Survey shows need for greater consistency in “real world” observational research

Continuum Clinical's ninth annual survey reveals that drug and device companies understand the value of real world studies, but continue to struggle with strategic, operational and organisational hurdles.

New stem cell delivery method shows promise for treating end stage...

A new clinical trial to test how a high dose of stem cells delivered via a method called retrograde coronary sinus infusion affects end stage heart failure patients is showing promising results.

Sunshine Heart provides update on COUNTER HF US study for C-Pulse...

COUNTER HF is a prospective, randomised, multicentre, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure.

Micell Technologies announces first patient enrolled in registration trial of MiStent...

Micell Technologies has begun enrolling patients in DESSOLVE C: a prospective, single-blind, multicentre, randomised, controlled clinical trial to demonstrate the efficacy and safety of its MiStent SES sirolimus-eluting absorbable polymer coronary stent system.

Hospira announces US launch of generic bivalirudin for injection

Hospira’s bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available.

Global bioabsorbable scaffolds market will be worth more than US$2bn by...

The growth will be driven primarily by new product approvals and a paradigm shift in the clinical treatment of vascular diseases towards minimally-invasive procedures, says research and consulting firm GlobalData.

EUROMAX substudy suggests transradial approach does not improve clinical outcomes

Contrary to the results of previous studies, according to a substudy of the EUROMAX trial, the transradial approach for coronary interventions is not associated with an improvement in clinical outcomes compared with the transfemoral approach.

Phil Mui joins HeartFlow product and engineering team

A former technology executive of Google and Acxiom, Mui will be responsible for guiding the scalable development of HeartFlow's technology platform.

Definitive agreement between St Jude Medical and Thoratec announced

St Jude Medical and Thoratec have announced that the Boards of Directors of both companies have unanimously approved a definitive agreement under which St Jude Medical will acquire all of the outstanding shares of Thoratec for $63.50 per share in a cash transaction valued at approximately $3.4 billion, net of cash acquired.

CE mark and FDA approval for new TAVI guidewire

Boston Scientific has received the CE Mark and FDA clearance for its Safari2 pre-shaped guidewire-a new and enhanced version of the Safari guidewire-for introducing and placing interventional devices within the heart (including those used in transcatheter aortic valve implantation).

A NOTION of things to come in TAVI

CardioSource World News talks with Hans Gustav HÌürsted Thyregod, about the NOTION study - the first all-comers trial to randomise low-risk patients to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement.

Strut coverage: Optical coherence tomography and new stent technologies

Tim Kinnaird explores the risk of stent thrombosis with current technologies, how new technologies may be able to reduce this risk, and how OCT can help to assess this risk.

Boston Scientific launches bioresorbable scaffold trial

Boston Scientific has initiated a study to evaluate its fully resorbable scaffold technology. FAST (Fully absorbable scaffold feasibility study) is a prospective, single-arm study designed to assess the safety and performance of this next-generation scaffold.

OrbusNeich announces enrolment of first patient in China Recovery Study

The China Recovery Study is designed to evaluate the performance of OrbusNeich’s Combo stent compared with the Nano stent (Lepu Medical Technology).

HeartWare announces first human implants of the MVAD System in CE...

The MVAD Pump is a heart pump that supports a wide range of flows to enable circulatory support for patients with advanced heart failure.

Vital’s CT myocardial perfusion makes its US debut at SCCT 2015

Vital Images’ 510(k) FDA-cleared computed tomography (CT) myocardial perfusion application is debuting at the 10th Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT; 16-19 July, Las Vegas).

US hospital is first hospital in world to use 4D ultrasound...

Aurora St Luke's Medical Center (Milwaukee, USA), a national leader in heart and vascular care, has become the first hospital in the world to use 4D ultrasound software, designed by GE Healthcare, to evaluate heart conditions.

Distal Access sells rights to SPNIR platform to Merit Medical

Distal Access has announced that it has sold the rights to its SPINR platform for peripheral, coronary, and endoscopic use to Merit Medical System's NRI Limited. The SPINR high-performance guidewire controller is designed to improve guidewire control, torque, and performance.

Men believe “long working hours” stop women from being interventional cardiologists

According to a new survey published in EuroIntervention, men state that the long working hours and the need to be on call that is associated with being an interventional cardiologist are the key reasons why so few women choose the subspecialty.

Enrolment in COAST study of orbital atherectomy system completed

Cardiovascular Systems has completed enrolment in COAST (Coronary orbital atherectomy system trial), which is designed to assess the safety and efficacy, as well as economic outcomes, of the company's new micro crown Orbital Atherectomy System (OAS).

Sorin launch latest generation of its healing and cooling system

Sorin has announced the global launch of its latest generation of heating and cooling system. The company reports that the FlexTherm-the newest addition to Sorin Heartlink System-is fully integrated with Sorin S5 industry-leading heart-lung machine.

Edwards Lifesciences enters into agreement to buy CardiAQ

Edwards Lifesciences has announced that it has agreed to acquire CardiAQ Valve Technologies, a privately held company and developer of a transcatheter mitral valve implantation (TMVI) system.

HeartMate PHP now has the CE mark

Thoratec has announced that its HeartMate PHP (Percutaneous Heart Pump) has received CE mark approval, permitting sale in the EU and other international countries. The approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE mark trial.

FDA approves Promus Element Plus and Promus Premier coronary stent systems

The FDA has announced it has approved Boston Scientific's Promus Element Plus and Promus Premier everolimus-eluting, platinum chromium coronary stent systems (monorail and over-the-wire) systems.

US generic version of bivalirudin authorised

The Medicines Company has authorised, in an agreement with Sandoz, the distribution of an authorised generic of bivalirudin (Angiomax) for injection in the USA. The company states that the agreement will help to ensure that bivalirudin remains a high quality product in this market.

FDA strengthen warnings about risk of myocardial infarction with NSAIDS

The FDA has strengthened its existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of myocardial infarction (or stroke). This follows, according to the agency, a comprehensive review of new safety information.

Nearly one third of PCI deaths are related to acute kidney...

A new study indicates that nearly one third of in-hospital deaths after PCI can be attributed to acute kidney injury. It also shows that preventing nine cases of acute kidney injury could potentially prevent one death.

Early discharge after TAVI is feasible in selected patients

A retrospective analysis, published in Heart, indicates that early discharge after transfemoral TAVI in selected patients does not increase the risk of death at 30 days compared with later discharge.

Invisible impact: The risk of ionising radiation on cath lab staff

This ORSIF video tells the story of one of the world's most prominent cardiovascular surgeons, Edward Diethrich, and the career-altering health issues he has faced as a result of chronic, low-level exposure to ionising radiation through his work.

CardioCel shows no evidence of calcification after seven years in long-term...

Admedus has announced positive long-term data from the CardioCel phase II clinical trial assessing the efficacy and safety of the company's proprietary bio-scaffold which has been implanted to repair congenital heart disease defects.

Thoratec announces first HeartMate 3 implant in European less invasive surgical...

The implant begins a European study to evaluate outcomes and complications using less invasive surgical placement through hemisternotomy and left thoracotomy techniques.

Trend towards better outcomes with sutureless valve for high-risk patients

A study indicates that surgical aortic valve replacement using the right anterior minithoracomy approach and a sutureless valve is associated with a trend towards better postoperative outcomes than those with TAVI

Oxford University Press launches European Heart Journal-Quality of Care and Clinical...

EHJQCCO is the eleventh European Society of Cardiology journal and focuses on the quality of care affecting cardiovascular outcomes at hospital, regional, national, and international level.

Will the DAPT trial change my practice? The Asian perspective

Chee Tang Chin presents his group's paper on the Asian perspective of the DAPT trial published in AsiaIntervention and also asks Thomas Cuisset for his projection for DAPT therapy in Europe.

The second generation of drug-eluting stents with biodegradable polymers may have...

Drug-eluting stents with biodegradable polymers have theoretical advantages over drug-eluting stents with permanent polymers-even second-generation drug-eluting stents.

Bureaucracy leads to delays in patients accessing cardiovascular devices

Patients are experiencing significant delays in access to approved cardiovascular devices due to bureaucratic inefficiencies, a Devices White Paper from the Cardiovascular Round Table (CRT) has found.

Miracor Medical Systems appoints international scientific advisory council

Miracor Medical Systems has appointed an international scientific advisory council consisting of leading clinicians to support the further clinical and technological progress of its PiCSO acute myocardial infarction impulse system.

Cell Therapy reports 100% MACE-free survival after two years in the...

At the International Society of Stem Cell Research Annual Conference (24-27 June, Stockholm, Sweden), the company also reported a 70% quality of life improvement measured by the MLHF questionnaire.

Cardiac Dimensions announces initial enrolments in REDUCE FMR clinical trial

The study is the first blinded, randomised clinical trial evaluating a mitral valve repair device in patients with functional mitral regurgitation.

FDA approves Medtronic’s CoreValve Evolut R

Medtronic has announced that the FDA has approved its recapturable, self-expanding CoreValve Evolut R TAVI system.

Tailored patient education may help to improve adherence to medications

Robin Mathews (Duke Clinical Research Institute, Duke University Medical Centre, Durham, USA) and others report, in Circulation: Cardiovascular Quality Outcomes, that tailored patient education may represent an opportunity to optimise patient adherence.

The importance of the PLATINUM DIVERSITY trial

The PLATINUM DIVERSITY trial was initiated last year with the aim of evaluating the clinical outcomes of an everolimus-eluting stent (Promus Premier, Boston Scientific) in patient populations that have been traditionally under-served by clinical trials (eg. women and minorities).

Admedus granted Cardiocel approval in Singapore

The application was based on the submission for US Food and Drug Administration (FDA) approval, which includes indications for use in cardiovascular repairs, suture buttressing and vascular and vessel repairs in both adults and children.

Learn About the “After the Stent” Campaign

Jeffrey Cavendish, interventionalist and member of The Society for Cardiovascular Angiography and Interventions (SCAI) Foundation, and Donnette Smith, executive vice president of Mended Hearts, discuss the "After the Stent" campaign.

CardiAQ reports first-in-human percutaneous implantation with its second generation transcatheter bioprosthetic...

The second-generation bioprosthetic mitral heart valve was implanted into a 72-year-old male suffering from severe mitral regurgitation (MR 4+) with multiple co-morbidities and ineligible for alternate treatment modalities.

Sapien 3 now approved for use in the USA

Edwards Lifesciences has announced that the FDA has approved its latest transcatheter aortic valve implantation (TAVI) system-Sapien 3-for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.

First US patient enrolled in BIOFLOW-V study of Orsiro

The first US patient-Biotronik has revealed-has been enrolled in the BIOFLOW-V clinical study of the Orsiro hybrid drug-eluting stent. The aim of the study is further demonstrate the safety and effectiveness of the device.