MassDevice

Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy

Edwards Lifesciences announced today that its Sapien M3 mitral valve replacement system received FDA approval for mitral ...
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.
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 ...
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 ...

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 ...
Orange County Business Journal

Edwards Comeback Continues on OK for Sapien XT

Edwards Lifesciences Corp.’s next generation of less-invasive heart valves is making its domestic debut, providing a boost that has extended a monthslong rally for shares of the Irvine-based heart ...
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 ...
Orange County Business Journal

Edwards Ready to Roll on Sapien Sales

Irvine-based Edwards Lifesciences Corp. is wasting no time getting its recently approved heart valve on the market here. Edwards Sapien is a less-invasive device that’s widely considered one of the ...
TCTMD

Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter Mitral and Aortic Valve-in-Valve Procedures

IRVINE, CA. -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark in Europe for valve-in-valve ...