The FDA today issued a notice warning of a recall of arterial perfusion cannula devices made by Edwards Lifesciences (NYSE: EW). Edwards offers its arterial perfusion cannulae for adult patients undergoing cardiopulmonary bypass. They provide arterial perfusion of oxygenated blood in the extracorporeal circuit for up to six hours. The company … [Read more...] about Edwards recalls certain arterial cannula devices
Edwards Lifesciences
Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE:EW) announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe. The launch expands the continent’s minimally invasive treatment options to a broader range of patients with congenital heart conditions. Edwards recently received CE mark for … [Read more...] about Edwards launches Sapien 3 valve with Alterra prestent in Europe
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year's 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott had data on display for a range of products, while other big … [Read more...] about The biggest cardiovascular stories from TCT 2023
The 24 best medical device innovations of 2022
The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products … [Read more...] about The 24 best medical device innovations of 2022
FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system. Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It features a low-profile frame for avoiding obstruction of the … [Read more...] about FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position
Edwards touts trial results for Evoque transcatheter tricuspid valve replacement system
Edwards Lifesciences (NYSE:EW) shared data from a clinical trial showing that its Evoque transcatheter tricuspid valve replacement offers favorable patient outcomes. Irvine, California–based Edwards presented the data during the late-breaking clinical science session at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), according to a … [Read more...] about Edwards touts trial results for Evoque transcatheter tricuspid valve replacement system
Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says
Edwards Lifesciences (NYSE:EW) today touted a cost-effectiveness analysis that supports transcatheter aortic valve replacement (TAVR) with the Sapien 3. Irvine, California-based Edwards presented data from the Partner 3 trial during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual … [Read more...] about Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says
3 pitfalls to consider when creating catheter delivery systems
Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls. A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on its end … [Read more...] about 3 pitfalls to consider when creating catheter delivery systems
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 … [Read more...] about The 18 most innovative medical devices of 2021
Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients
Edwards Lifesciences‘s Evoque tricuspid valve replacement system reduces tricuspid heart valve leakage to non-traceable or mild leakage in 98% of patients, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session. Evoque is designed to replace native tricuspid valves without open-heart surgery. The … [Read more...] about Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients
