Nasdaq

Edwards SAPIEN M3 Receives CE Mark, Becoming World’s First Transfemoral Transcatheter Mitral Valve Replacement System

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment ...
Nasdaq

Edwards SAPIEN 3 TAVR Delivers Proven Long-term Benefits and Valve Performance, New Data Presented at TCT 2025

SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR. The ...
Business Wire

Successful Patient Outcomes Demonstrated With Edwards’ SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025

One-year outcomes in the ENCIRCLE trial’s main cohort (299 patients unsuitable for other treatment options) achieved low rates for death and low heart failure hospitalization for patients treated with ...
Hosted on MSN

FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients

The US Food and Drug Administration (FDA) has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for the treatment of patients with asymptomatic severe ...
The Washington Post

Artificial Sapien heart valve sparks safety questions as wider use is considered

Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, in advance of a meeting Wednesday to consider broadening its ...
MD&M East

Edwards Secures US-First Approval for Mitral Regurgitation Treatment

Edwards Lifesciences’ SAPIEN M3 mitral valve replacement system has become the first transcatheter therapy utilizing a transseptal approach to snag FDA approval in the U.S. for the treatment of mitral ...