Claret Medical, a developer of solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures, announced that it has received CE mark for the Sentinel cerebral protection system for embolic protection during transcatheter aortic valve implantation (TAVI). The product will launch immediately in selected CE mark countries.
Edwards Lifesciences has announced its transcatheter heart valve—Sapien XT—has received CE-mark approval to be used in valve-in-valve procedures for the both the aortic valve and the mitral valve in patients who are at extreme risk for surgery. The company is the only company to receive a valve-in-valve indication for the mitral position.
Neovasc has announced that a first-in-human implantation of its Tiara transcatheter mitral valve was successfully performed on January 30th by physicians at St. Paul’s Hospital in Vancouver, Canada. The transapical procedure resulted in the elimination of mitral regurgitation and significantly improved heart function in the patient, without the need for cardiac bypass support and with no procedural complications.
Jason Wasfy (Cardiology Division, Massachusetts General Hospital, Boston, USA) and others report in Circulation: Cardiovascular Interventions that recurrent chest discomfort is the most common cause for readmission after percutaneous coronary intervention (PCI). They add that patients readmitted for chest discomfort are associated with high rates of diagnostic imaging but frequently do not meet the criteria for myocardial infarction.
In Eurointervention, Joep Perk (Linnaeus University, Kalmar, Sweden) and others report that most patients do not appreciate that cardiovascular disease is a chronic condition with many believing that percutaneous coronary intervention (PCI) is a complete cure. The authors state that this shows that there is a need for considerable revision of cardiac rehabilitation.
Edwards Lifesciences has announced that it has received Investigational Device Exemption (IDE) approval from the FDA to initiate a single-arm, non-randomised clinical trial of its Sapien 3 transcatheter aortic valve implantation (TAVI) device for the treatment of intermediate risk patients with severe symptomatic aortic stenosis. The company also completed enrolment in its US clinical trial of Sapien 3 valve in the treatment of high-risk or inoperable patients.
On-X Life Technologies has announced today that its previously CE-marked On-X prosthetic heart valve has received European regulatory approval for an expanded labelling claim, which now permits the company to market its valve with a reduced requirement for the use of blood-thinning drugs such as warfarin. A press release reports that branded On-X Plus 1.5 aortic heart valve is now the only heart valve that allows patients to be managed at INR levels as low as 1.5
Elixir Medical has announced the first commercial implant of its CE mark-approved DESolve novolimus-eluting coronary scaffold, which is designed to degrade within one year, has taken place in Germany. The procedure was performed by Holger Nef, head of the Cardiac Catheterization Laboratory, University Hospital Giessen, Giessen, Germany.
Medtronic has announced the FDA approval of its self-expanding transcatheter CoreValve system for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk study of the CoreValve US Pivotal trial.
Although previous studies have shown that pacemaker implantation is associated with increased mortality and heart failure hospitalisation, a new study in Circulation has not found an association between permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) and an increased risk of all-cause mortality or heart failure hospitalisation.
BioCardia has announced receipt of the CE mark for its Helix 953L catheter as part of its Helix transendocardial delivery system for infusion of biologics to the heart. The new catheter is optimised for larger, dilated hearts, while maintaining compatibility with smaller hearts. It also does not require biotherapeutic programmes already using the Helix system for delivery to develop new compatibility data. The Helix 953L catheter will be commercially available in the European Union in the coming months.
Direct Flow Medical has announced that it has received the CE mark for the first fully repositionable 29mm transcatheter aortic heart valve, delivered through its flexible, 18 French transfemoral delivery system. The transcatheter aortic valve implantation (TAVI) device is designed to virtually eliminate aortic regurgitation in all sizes of annulus by allowing complete assessment of haemodynamic performance and unlimited repositioning of the valve after full deployment in the native valve annulus.
MediValve has announced that it has received European pre-market clearance for its acWire guidewire, which completes the CE registration process for the device. The acWire is specifically intended for implantation plane acquisition during transcatheter aortic valve implantation procedures, using fluoroscopic imaging.
Tryton Medical has announced the launch of its “Bifurcation Institute”, which it says is a comprehensive education resource that has been established to advance the standard of care for bifurcated coronary artery disease. Membership for the institute is free and provides physicians with access to e-newsletters that summarise recent clinical data and news.
The American College of Cardiology (ACC), along with nine key specialty and subspecialty societies, has published a document assessing 80 potential clinical scenarios with the goal of assisting physician and patient decision-making. The criteria identify common scenarios in clinical practice and provide a level of appropriateness for the technology’s use based on a risk-benefit analysis.
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