sharewise

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 ...
Pharmabiz

US FDA approves Edwards Lifesciences' SAPIEN M3 mitral valve replacement system, a first transseptal transcatheter therapy to treat mitral regurgitation

Irvine, California Friday, December 26, 2025, 11:00 Hrs [IST] ...
Medical Device Network

Edwards receives FDA approval for mitral valve replacement system

Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...
Nasdaq

Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System Wins FDA Approval

(RTTNews) - Edwards Lifesciences Corp. (EW) on Tuesday said its SAPIEN M3 mitral valve replacement system received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral ...
Investing

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved mitral valve system

IRVINE, California - Edwards Lifesciences (NYSE:EW) has received U.S. Food and Drug Administration approval for its SAPIEN M3 mitral valve replacement system, marking the first transcatheter therapy ...
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 ...
The Barre-Montpelier Times Argus

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

The SAPIEN M3 system received CE Mark in April 2025, making it the world’s first approved transfemoral transcatheter mitral ...
Becker's ASC

Kentucky hospital performs 1st-of-its-kind tricuspid valve replacement in state

Louisville, Ky.-based Norton Heart & Vascular Institute performed Kentucky’s first transcatheter tricuspid valve replacement using the Evoque system. The catheter-based procedure, developed by Edwards ...
Morningstar

Edwards Lifesciences Reaffirms Strategy for Sustainable, Differentiated Growth at Annual Investor Conference

Edwards Lifesciences (NYSE: EW) will outline its patient-focused strategy and share financial guidance during its annual investor conference. Entering 2026 with momentum for sustainable differentiated ...