MedTech Dive

Edwards receives FDA approval for mitral valve replacement system

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.
Medical Device and Diagnostic Industry (MD+DI)

Edwards Secures US-First Approval for Mitral Regurgitation Treatment

First-of-its-kind Edwards SAPIEN M3 transcatheter mitral valve system secures FDA approval for transseptal mitral ...
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 ...
Fierce Biotech

Edwards nets FDA approval for Sapien M3 transcatheter mitral valve replacement

Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking the ...
Zacks Investment Research 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 ...
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 ...
BioWorld

Edwards Lifesciences is first in mitral valve repair with FDA approval of Sapien 3

Edwards Lifesciences Corp. won FDA approval for its Sapien 3 transcatheter heart valve device for aortic and mitral valve-in-valve procedures. The Irvine, Calif.-based company leads the way in a ...
Orange County Business Journal

Edwards, Hoag Join Forces on Sapien Debut

Hoag Memorial Hospital Presbyterian in Newport Beach will be among one of the first U.S. hospitals to offer a much-touted medical device from a device maker here. Irvine-based Edwards Lifesciences ...
Orange County Business Journal

FDA Clears Additional Use for Edwards Sapien XT

Irvine-based Edwards Lifesciences Corp. said today that the Food and Drug Administration approved its Edwards Sapien XT replacement heart valve for aortic valve-in-valve procedures. Valve-in-valve ...