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 ...
Business Wire

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 of ...
Medical Xpress

FDA approves SAPIEN 3 platform for asymptomatic severe aortic stenosis

The U.S. Food and Drug Administration has approved Edwards Lifesciences' SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe aortic stenosis without ...
Seeking Alpha

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

SAPIEN 3, which showed superiority at 1 year, also demonstrates compelling outcomes equivalent to surgery at seven years SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced ...
Hosted on MSN

EW wins FDA approval for SAPIEN M3 as first transseptal TMVR therapy

Edwards Lifesciences EW announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first minimally invasive, catheter-based treatment that uses a ...