Medtronic shared positive data from a study of its Intrepid transcatheter mitral valve replacement (TMVR). The medtech giant presented one-year results from the Intrepid early feasibility study at TCT 2023. It simultaneously published the data in JACC: Cardiovascular Intervention. Medtronic says the study demonstrated the early benefits of the Intrepid TMVR-transfemoral system, maintained up to […]
Replacement Heart Valves
Edwards wins CE mark for Evoque tricuspid valve replacement
Edwards Lifesciences announced today that it received CE mark for its Evoque tricuspid valve replacement system. Irvine, California-based Edwards says the regulatory nod makes it the first transcatheter valve replacement therapy to receive approval to treat tricuspid regurgitation (TR). Evoque features a nitinol self-expanding frame and an intra-annular sealing skirt. It makes the device’s tissue […]
Report: Patent practices triggered EU antitrust probe into Edwards
Reuters reports that European officials probed Edwards Lifesciences over potential antitrust activity because of patent practices. The outlet cites a person familiar with the matter regarding the European Commission’s scrutiny of the U.S.-based medtech company. Last month, the European Commission said it conducted a surprise inspection at an undisclosed medtech company. It listed that company […]
Medtronic Evolut FX TAVI wins CE mark approval
Medtronic this week announced it received CE mark approval for the Evolut FX transcatheter aortic valve implantation system. The Evolut FX is the latest generation TAVI of the company’s CoreValve/Evolut TAVI platform. Medtronic designed it to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis. […]
FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
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 — […]
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 […]