Seeking Alpha

FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach ...
Seeking Alpha

Edwards Lifesciences wins FDA nod for SAPIEN M3 TMVR system

Edwards Lifesciences (EW) announced on Tuesday that the U.S. Food and Drug Administration approved its SAPIEN M3 transcatheter mitral valve replacement (TMVR) system for patients with mitral ...
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 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 data ...