Boston Scientific (NYSE:BSX) today touted positive 24-month results from a trial evaluating its Watchman FLX left atrial appendage closure device. Marlborough, Mass.-based Boston Scientific’s Watchman FLX LAAC device for patients with non-valvular atrial fibrillation (NVAF) had previously proven its safety and efficacy in 12-month data from the same trial presented in April. The latest data, […]
Replacement Heart Valves
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
Vivasure Medical initiates development of sutureless venous closure device
Vivasure Medical announced today that it launched a development program for its PerQseal Blue investigational product. Galway, Ireland-based Vivasure designed PerQseal Blue for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, including transcatheter mitral valve repair/replacement (TMVR) and transcatheter tricuspid valve repair/replacement (TTVR). According to a news release, the company based […]
FDA grants PMA to Abiomed’s next-generation Impella RP
Abiomed (NSDQ:ABMD) announced today that the FDA granted premarket approval (PMA) to its Impella RP with SmartAssist. Danvers, Mass.–based Abiomed received PMA for the Impella RP right heart pump with SmartAssist as a safe and effective treatment for acute right heart failure for up to 14 days, according to a news release. The company touts […]
Medtronic stops sales of its HVAD system
Medtronic (NYSE:MDT) announced today that it has stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system. Fridley, Minn.-baed Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release. […]
LivaNova moves forward with heart valve business sale
LivaNova (NSDQ:LIVN) announced today that it completed the initial closing of the sale of its heart valve business to Gyrus Capital. In December, LivaNova announced its board’s unanimous approval of the divestiture of the heart valve business to enable the company to “sharpen its focus” within its primary platforms, such as neuromodulation and cardiovascular. According […]
Boston Scientific’s Acurate Neo performs well in latest trials
Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system. Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and Ital-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release. Results from the Early neo2 Registry of 554 patients across […]
Evolut TAVR just as good as open-heart surgery among younger people, Medtronic says
Medtronic (NYSE:MDT) today touted two-year outcomes for a trial comparing its Evolut TAVR system to open-heart surgery in younger people. Fridley, Minn.-based Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system went up against the gold standard of open-heart surgery in younger, healthier aortic stenosis patients in the trial, which had its results presented as a […]
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
Abbott wins CE mark for Navitor TAVI
Abbott (NYSE:ABT) announced today that it received CE mark approval for its Navitor transcatheter aortic valve implantation (TAVI) system. The latest-generation TAVI system from Abbott, Navitor won European approval for treating those with severe aortic stenosis who are at high or extreme surgical risk, according to a news release. Navitor uses Abbott’s FlexNav delivery system […]
Medtronic wins CE mark approval for Evolut Pro+ TAVI system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]
