By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
Edwards Lifesciences
Medtronic says Evolut TAVR outperformed Edwards Sapien in head-to-head trial
Medtronic today announced data from a head-to-head trial backing its Evolut TAVR system against the Edwards Sapien platform. The medtech giant presented results from the one-year SMART trial at the American College of Cardiology Annual Scientific Session. It simultaneously published the study results in The New England Journal of Medicine. SMART evaluated Evolut and Sapien […]
Edwards Lifesciences’ chair Michael Mussallem retires from board
Edwards Lifesciences announced that Chair Michael Mussallem is retiring from the board of directors a year after stepping down as CEO. Mussallem became a non-executive chair of the Irvine, California-based company after he retired from his CEO post on May 11, 2023. He is expected to be succeeded by independent director Nicholas Valeriani, who will […]
Edwards reports ‘excellent’ outcomes with Sapien TAVR
Edwards Lifesciences announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system. Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024. A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found […]
TAVR, Critical Care drive Edwards to Q4 sales beat
Edwards Lifesciences shares dipped slightly today on fourth-quarter results that topped the consensus sales forecast. Shares of EW fell 0.2% to $88.11 in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%. The Irvine, California-based company posted profits of $369.9 million. That equals […]
Edwards wins FDA approval for its Evoque replacement tricuspid valve
Edwards Lifesciences announced today that the FDA granted approval for its Evoque tricuspid valve replacement system. The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first […]
Edwards plans to spin off critical care business next year
Edwards Lifesciences announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart […]
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 released data covering a range of products, while other big names like Edwards, GE […]
Edwards wins CE mark for Mitris Resilia valve
Edwards Lifesciences announced today that it received CE mark approval for its Mitris Resilia tissue valve replacement. News of the latest regulatory milestone follows the receipt of CE mark approval for the Evoque valve system last week. Edwards also reported positive TAVR data at TCT 2023 and recorded third-quarter sales growth in its latest earnings […]
Edwards Lifesciences says TAVR drove 12% sales growth in Q3
Edwards Lifesciences reported third-quarter results that met Wall Street expectations, with solid sales growth keeping it on track to boost revenue by up to 13% this year. Investors may have expected more from the maker of catheter-delivered heart implants, including transcatheter aortic valve replacement systems and transcatheter mitral and tricuspid therapies. The morning after the […]
5-year data supports Edwards Lifesciences’ Sapien 3 TAVR
Edwards Lifesciences announced new data demonstrating continued positive outcomes with its Sapien 3 transcatheter aortic valve replacement (TAVR). Results from the PARTNER 3 trial showed continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. Edwards presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) in San Francisco. It simultaneously published […]