Edwards Lifesciences shares dipped despite first-quarter results that topped the consensus forecast. Shares of EW were down slightly to $86.72 apiece by the close of trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up slightly. The Irvine, California–based medical device maker yesterday […]
Replacement Heart Valves
Medtronic issues TAVR safety notice in Europe
Medtronic issued an urgent field safety notice for its replacement heart valve in Europe. The warning covers the Medtronic CoreValve Evolut Pro+ 34 mm transcatheter aortic valve replacement (TAVR). It’s dated December 2022, although it was published to a European regulatory site last week. Medtronic notified customers of a “known phenomenon” that occurs when the […]
Abbott wins FDA nod for Epic Max stented tissue valve
Abbott announced today that the FDA approved its Epic Max stented tissue valve for treating aortic regurgitation or stenosis. The latest addition to Abbott’s Epic surgical valve platform features an optimized design to further improve blood flow. In 2021, the FDA approved the next-generation Epic Plus and Epic Plus Supra stented tissue valves. Epic Max, […]
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, cardiac […]
Edwards Lifesciences finds low re-intervention rates at 10 years for TAVR patients
Edwards Lifesciences (NYSE:EW) today announced data supporting transcatheter aortic valve replacement (TAVR) at 10 years. An analysis of Medicare data showed a low rate of re-intervention after TAVR out to 10 years. Dr. Suzanne Baron, a Boston-based interventional and structural cardiologist, led the analysis. Edwards presented results at the American College of Cardiology ACC.23/WCC. Of […]
Medtronic touts 3-year data for Evolut TAVR
Medtronic (NYSE:MDT) announced three-year data supporting its Evolut transcatheter aortic valve replacement (TAVR) system. Findings from the Evolut Low-Risk trial demonstrated numerically better clinical outcomes for the Evolut TAVR system. It also showed significantly better hemodynamic valve performance compared to surgical aortic valve replacement (SAVR). The study evaluated a low-risk aortic stenosis (AS) patient population. […]
Abbott reports positive study results for MitraClip, TriClip heart valve repair devices
Abbott (NYSE:ABT) announced late-breaking data supporting both its MitraClip and TriClip heart valve repair devices. Five-year data from the COAPT trial demonstrated the safety and efficacy of MitraClip for people with mitral regurgitation (MR). Data also showed the superiority of the TriClip transcatheter edge-to-edge repair (TEER) system. The Triluminate pivotal study evaluated TriClip against medical […]
Data backs Abbott Navitor, Amulet heart implants
Abbott (NYSE:ABT) announced today that studies support its next-generation Navitor TAVI system and its Amplatzer Amulet device. Results from the Navitor study supported recent FDA approval for the transcatheter aortic valve implantation (TAVI) system. The FDA last month approved the system for treating severe, symptomatic aortic stenosis in those at high or greater risk for […]
Abbott says its Trifecta heart valves could deteriorate early
Abbott (NYSE:ABT) and the FDA are telling health providers that the company’s Trifecta family of heart valves could deteriorate early. Published literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) for Trifecta valves compared to other commercially available valves, according to a letter to healthcare providers that the FDA published today. The […]
Data backs durability of Medtronic CoreValve Evolut TAVR
Medtronic (NYSE:MDT) today announced five-year data that supports its CoreValve Evolut transcatheter aortic valve replacement (TAVR) implant. Dr. Steven Yakubov presented findings at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023). The data showed significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR). Medtronic’s study evaluated bioprosthetic valve dysfunction […]
Medtronic relaunches Harmony transcatheter pulmonary valve system
Medtronic (NYSE:MDT) announced today that it relaunched its Harmony transcatheter pulmonary valve (TPV) system. The non-surgical heart valve for treating severe pulmonary valve regurgitation first received FDA clearance in March 2021. It treats congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). Harmony provides a minimally invasive alternative for patients […]