EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system. The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures. According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — […]
Replacement Heart Valves
Report: Edwards is cooperating with EU amid antitrust scrutiny
According to reports, Edwards Lifesciences is the company under scrutiny in Europe for potential antitrust activity. Reuters reports that the company is working with EU antitrust regulators on the matter. The European Commission said last week that it conducted a surprise inspection at an undisclosed medtech company. It listed that company as active in the cardiovascular […]
Boston Scientific completes enrollment in next-gen aortic valve registry
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 […]
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 […]
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 […]
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 […]
Foldax treats first patients outside U.S. with polymer mitral heart valve
Foldax announced today that the first 30 patients have been treated outside the U.S. with its Tria polymer surgical mitral heart valve. The procedures took place as part of the commencement of a clinical trial in India. Tria remains investigational and not available for commercial sale. Salt Lake City-based Foldax designed Tria to accommodate the […]
Abbott is pulling its Trifecta valves off the market
Abbott announced today that it is withdrawing its Trifecta family of heart valves from worldwide markets. The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early. In a statement shared with MassDevice, the company said: “Abbott has decided to withdraw and discontinue its […]
Anteris Technologies touts first successful implant of DurAVR THV in valve-in-valve procedure
Anteris Technologies announced today that surgeons used its DurAVR heart valve for the first time in a valve-in-valve (ViV) procedure. Brisbane, Australia-based Anteris — which has U.S. operations in Minneapolis — designed TurAVR THV as a new class of biomimetic heart valve. The company says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped […]
TAVR sales were up 9% for Edwards in Street-beating Q2
Edwards Lifesciences shares fell after hours today despite second-quarter results that beat the consensus forecast. Shares of EW dipped 6.3% to $85.85 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.6%. The Irvine, California-based company posted profits […]
Onecrea Medical completes first-in-human implants of TAVR system
Onecrea Medical recently announced that it successfully completed first-in-human implants for its transcatheter aortic valve replacement (TAVR) system. The company designed its next-generation TAVR system to treat aortic stenosis. With a unique concave and convex structure, the TAVR system anchors the valve effectively in the aortic annulus. This helps to avoid common complications with TAVR, […]
