Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment. The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across […]
Cardiac Implants
FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial. BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker. New […]
TAVR tech developer JenaValve adds J&J vet to its board
JenaValve Technology announced that it appointed cardiovascular industry veteran Shlomi Nachman to its board of directors. Nachman brings more than 25 years of experience to the transcatheter aortic valve replacement (TAVR) system maker’s board. He previously held senior operating roles at Johnson & Johnson. That included serving as company group chair of cardiovascular and specialty […]
FDA approves next-gen Watchman FLX Pro from Boston Scientific
A string of positive news continues for Boston Scientific , which today announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA 510(k) clearance for its […]
HighLife unveils new large annular valve for mitral regurgitation clinical trials
HighLife SAS announced today that it introduced a new valve size in its clinical trials for treating mitral regurgitation (MR) in larger anatomies. Paris-based HighLife’s latest trans-septal mitral valve replacement (TSMVR) is a large annulus valve (LAV). The company designed it to fit within its existing delivery catheter and to accommodate large annuli up to […]
Biotronik announces first U.S. implant of next-gen pacemaker
Biotronik today announced the first U.S. implantation of its new, next-generation Amvia Edge pacemaker system. The FDA approved the Biotronik portfolio of Amvia Edge pacemakers last month. Dr. Raul Weiss completed the procedure at Mount Sinai Medical Center in Miami, Florida. “I was very pleased to have been a part of the first implant of […]
PolyVascular, CobiCure partner on non-surgical pediatric heart valve
CobiCure Medical Technologies announced that it provided $2 million in funding to PolyVascular to advance a pediatric heart valve. Houston-based PolyVascular — a MedTech Innovator accelerator participant in 2020 — develops a first-of-its-kind heart valve. The potentially transformative, non-surgical valve could treat young children suffering from congenital heart disease. New York-based CobiCure, a non-profit pediatric […]
Study: Medtronic ICDs can help prevent sudden cardiac death
Medtronic today announced data demonstrating improved outcomes with its implantable cardioverter defibrillators (ICDs). ICDs treat dangerously fast or irregular heart rhythms — ventricular tachycardia or ventricular fibrillation — that can lead to sudden cardiac death (SCD). Two analyses demonstrated survival benefits and a reduction in life-threatening cardiac events with the use of ICDs. Data provided […]
Abbott study shows OCT intravascular imaging improves stent procedure outcomes
Abbott announced late-breaking data supporting the use of optical coherence tomography (OCT) imaging. The ILUMIEN IV OPTIMAL PCI study evaluated the use of OCT during percutaneous coronary interventions (PCI). OCT imaging offers additional high-definition images that improve the visualization of vessel structure. This provides doctors with actionable data that translate into patient benefits, potentially shifting […]
Magenta Medical completes enrollment in trial of tiny heart pump
Magenta Medical announced today that it completed enrollment for the early feasibility study of its Elevate heart pump device. The FDA-approved study evaluates the percutaneous left ventricular assist device (pLVAD) for high-risk percutaneous coronary intervention (HR-PCI). Investigators enrolled and successfully treated 15 study patients. Treatments took place at Mount Sinai Hospital, St. Francis Hospital and […]
FDA deems latest Abiomed Impella recall Class I
Abiomed, a Johnson & Johnson unit, issued another recall for some of its Impella heart pumps. This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge […]
