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...
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).
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.
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."
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 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.
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.
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.
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.
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.
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.
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.
A large cohort study, published in Catheterization and Cardiovascular Interventions, indicates that TAVI is associated with an overall 2% risk of upper gastrointestinal bleeding.
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.
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 has approved Abbott's Absorb bioresorbable heart stent, making the device commercially available to treat people in Canada with coronary artery disease.
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.
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.
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 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 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.
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.
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 â‰¤75 years at low surgical risk.
Martina PatanÃ© 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 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.
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.
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).
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 â‰¥2.5mm stent).
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.
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.
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.
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.
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.
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 has received certification for CE marking its Revivent TC transcatheter ventricular enhancement system.
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.
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.
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.
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.
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.
The Cardiac & Vascular Institute is the first organisation in the North Central Florida USA area of the USA to offer patients with non-valvular...
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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 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.
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.
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.
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 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.
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.
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).
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.
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.
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.
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.
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).
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.
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
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.
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 has received US Food and Drug Administration (FDA) investigational device exemption approval to initiate its pivotal ALIVE (American Less Invasive Ventricular Enhancement) clinical trial.
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.
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).
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.
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.
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 presented three-year results from its prospective, multicentre DISCOVER Trial at the 2016 EuroPCR meeting in Paris.
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 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 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 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.
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.
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.
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 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 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 (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.
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.
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.
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.
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.
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 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.
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 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.
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.
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 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.
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.
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 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 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.
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.
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 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.
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.
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.
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.
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 have introduced a new version of the Sonimage HS1 compact ultrasound system, which is designed to enable improved image quality.
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 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.
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 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.
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.
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 America Medical Systems'sAquilionTM Lightning has been cleared by the US Food and Drug Administration (FDA) with a more powerful 50-kW generator.
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.
La PitiÌ©-SalpÌ»triÌ¬re 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 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.
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.
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.
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, 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.
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.
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.
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.
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.
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 have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions iFR pressure measurement technology compared with FFR measurements.
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.
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 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.
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.
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.
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.
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.
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 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 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.
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 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.
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.
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.
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.
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.
The Xposition S (Stentys), a sirolimus-eluting self-apposing stent, has received CE marking for the treatment of unprotected left main coronary artery disease.
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.
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.
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.
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.
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).
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 has recalled the MitraClip clip delivery system, following reports of issues with the delivery system deployment process.
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.
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 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.
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 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 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 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.
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 (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.
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.
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.
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.
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.
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 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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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 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.
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 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.
Reva Medical has announced that more than 200 patients have been enrolled in its clinical study of its sirolimus-eluting bioresorbable coronary scaffold (Fantom).
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.
The 'Grants for Medical Research Innovation' are awarded to research projects that will address areas of unmet medical need in thromboembolic disease.
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 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.
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.
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.
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.
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.
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).
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, the founder and chief executive of The Medicines Company, has received the 2016 Sol J Barer Award for Vision, Innovation and Leadership.
In this commentary, Vinayak Bapat outlines transcatheter mitral valve interventions and reviews which specialists should comprise the optimal heart team for such procedures.
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'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.
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.
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.
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 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.
The platform, called Advantics Care Pathway Transformation, is designed to help improve patient outcomes and reduce costs to treat patients with chronic cardiovascular diseases.
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
Masieh Abawi and others report in JACC Cardiovascular Interventions that about 13% of patients develop postoperative delirium after undergoing transcatheter aortic valve implantation (TAVI).
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 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.
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.
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.
This commentary explores why the USA, despite the data supporting the transradial approach, has been more reluctant than other countries to adopt the approach.
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.
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, 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.
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.
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.
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.
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.
This acquisition is intended to bolster SurModic's vascular device expertise and research and development capabilities.
The statement is intended to provide cardiologists, oncologists and internal medicine physicians with guidance for treating patients facing both cardiovascular disease and cancer.
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 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 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 Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies.
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.
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.
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.
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.
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.
Patient delays have been associated with an increase in damage to the heart, according to a study published online in JACC: Cardiovascular Interventions.
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 sheath
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.
The company has also responded to comments from Engaged Capital, a new stockholder, regarding its proposed acquisition of Valtech Cardio.
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.
The CorPath system is designed to allow interventional cardiologists to perform procedures away from the patient bed side and the radiation source.
OrbusNeich presented the Sapphire II Pro and Scoreflex products at a case-in-point session at the course in Dubai, UAE.
Jean Marco, PCR honorary chairman, discussed "transformative learning" during a keynote lecture at the 2015 GulfPCR meeting.
This commentary reviews the benefits of providing psychological support for patients who experience emotional distress after having a myocardial infarction.
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.
This €3 million extension is intended to hasten Xeltis' pipeline development on a number of cardiovascular indications.
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.
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.
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 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 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
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.
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).
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.
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 (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.
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.
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).
The first implantation of BioVentrix' micro-anchor technology entirely within the left ventricle using a catheter-based endovascular approach has been successfully completed.
Medinol continued its introduction of its novel stent solutions during the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco.
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.
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.
Olcay Aksoy discusses how transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of patients with aortic stenosis.
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.
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.
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.
The first US patient has been enrolled in Mitralign's SCOUT study, which is evaluating the company's percutaneous tricuspid valve annuloplasty system (Trialign).
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.
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.
This structured approach could conflict with men's tendency to trust self-directed learning instead of self-management, say study authors.
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.
J Aaron Grantham describes the effect of using PCI to treat a patient with a CTO of the left anterior descending coronary artery.
Nurun Nahar Fatema talks about how Muntada Aid's Little Hearts campaign has helped children in Bangladesh with congenital heart problems.
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.
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.
Patients with heart disease who sit a lot have significantly worse body mass index and cardiorespiratory fitness, even if they exercise.
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.
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 has announced that it has acquired Coherex Medical, developers of the Coherex WaveCrest left atrial appendage (LAA) occlusion system. "The Coherex WaveCrest System...
The communication includes guidelines for healthcare providers treating patients during or after intravascular procedures.
A study has found that the size of individual hospitals is the only factor influencing their rate of 'never events'.
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.
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.
TATORT-NSTEMI is the first randomised trial investigating the impact of thrombectomy before percutaneous coronary intervention.
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.
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.
David L Martin, chief executive officer of Cardiovascular Systems is due to take approximately three months to focus on treatment for cancer.
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.
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.
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.
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.
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.
The New Haven Pharmaceuticals study analysed the effects of the company's "Durlaza" extended-release aspirin.
The wholly-owned facility is equipped to develop, test and deliver existing and improving valve technologies
In this ACC/MedPage Today video, Peter Block and Robert Yeh discuss the DAPT score, which Yeh presented at the 2015 AHA scientific sessions.
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.
A study has reported an efficient protein-based method for converting fibroblasts into cardiac progenitor cells (CPCs) directly.
WomenHeart: The National Coalition for Women with Heart Disease has appointed three women heart disease survivors.
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.
Researchers have created a novel library of healthy children's 3D reconstructed hearts using MRI and CT images.
Over a lifetime of work, women cardiologists earn more than US$1 million less than their male counterparts.
The prize was in recognition of his findings of artery wall predictors of cardiovascular disease risk.
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.
Peer group support has been found to improve healthy behaviour in people with cardiovascular risk factors.
The ability to register with more than one organ transplant centre seems to increase a patient's likelihood of receiving a transplant.
The trial has shown positive results in patients a year after surgery for Xeltis' products.
The product is now approved for use in the repair and construction of heart valves.
Innovations in echocardiography, cardiovascular magnetic resonance (CMR), nuclear cardiology and cardiac computed tomography (CT) will be presented and discussed during the meeting.
This study-which will recruit 100 patients-is taking place to support a pre-market approval (PMA) application to the FDA.
Based on a novel multi-ablation technology, ReDy claim that its renal denervation system delivers a pre-determined RF ablation with a single positioning.
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.
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).
The Harmony catheter-based neurostimulator device system is designed to treat congestive heart failure.
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.
The device's percutaneous approach is designed to be less traumatic for patients and to achieve shorter recovery times.
The launch is one stage of Admedus' ongoing global rollout of Cardiocel, which has now been implanted in over 3,000 patients.
The petitioners argue that health disparities continue along the lines of race and ethnicity, and that health profession needs to be culturally competent.
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.
The stent could become the first bifurcation stent available in the USA if approved.
Roxana Mehran encourages people to attend the 2016 Society for Cardiac Angiography and Interventions meeting
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.
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 has also begun pre-commercialisation activities for its Fractional Flow Reserve products.
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 has appointed D Scott Lim as national co-principal investigator for the SALUS pivotal trial. He joins co-principal investigator Isaac George.
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).
AV Medical Technologies has announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Chameleon angioplasty balloon catheter.
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.
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 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.
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.
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.
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.
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 (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
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.
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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.
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 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 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 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 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.
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 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.
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.
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.
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.
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.
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.
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.
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 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 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 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 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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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 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.
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 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.
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.
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 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.
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.
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.
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.
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 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.
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 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.
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.
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.
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.
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.
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.
The French registry is evaluating the Cobra PzF coronary stent system in patients with heart disease.
The company has also received US$1.4m of a US$2m bridge round to accelerate its clinical programme.
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.
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 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).
The supplemental New Drug Application seeks the addition of ST segment elevation myocardial infarction indication for Aggrastat.
The acquisition, which is subject to certain conditions, is expected to close in October 2015.
For EHJ today, Karl Swedberg moderates a discussion between Gerard Helft and Lars Wallentin about the OPTIDUAL study (which Helft presented at the ESC).
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.
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.
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.
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.
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.
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).
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.
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.
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 (head of Section, Interventional Cardiology Unit, Hospital Clinico San Carlos, Madrid, Spain) is a co-course director of EuroPCR (17-20 May, Paris, France).
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.
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.
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.
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)
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
Philippe GÌ©nÌ©reux 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.
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).
This European Society of Cardiology (ESC) video explores the role of comprehensive rehabilitation programmes for the secondary prevention of myocardial infarction.
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 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).
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.
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 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 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.
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.
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 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.
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.
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 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.
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 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 have entered into an exclusive agreement to distribute Artimes semi-compliant and Apollo non-compliant coronary angioplasty catheters.
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 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.
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.
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.
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.
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.
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.
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.
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 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).
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.
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.
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 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.
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.
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.
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 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’s bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available.
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.
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.
A former technology executive of Google and Acxiom, Mui will be responsible for guiding the scalable development of HeartFlow's technology platform.
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.
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).
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.
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 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.
The China Recovery Study is designed to evaluate the performance of OrbusNeich’s Combo stent compared with the Nano stent (Lepu Medical Technology).
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 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).
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 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.
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
The implant begins a European study to evaluate outcomes and complications using less invasive surgical placement through hemisternotomy and left thoracotomy techniques.
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
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.
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.
Drug-eluting stents with biodegradable polymers have theoretical advantages over drug-eluting stents with permanent polymers-even second-generation drug-eluting stents.
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 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.
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.
The study is the first blinded, randomised clinical trial evaluating a mitral valve repair device in patients with functional mitral regurgitation.
Medtronic has announced that the FDA has approved its recapturable, self-expanding CoreValve Evolut R TAVI system.
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 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).
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.
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.
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.
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.