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

Edwards Lifesciences EW announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making ...

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

The TMVR procedure with SAPIEN M3 involves dock and valve delivery via a percutaneous femoral vein guide sheath.

The US Food and Drug Administration has approved the Sapien M3 system for transseptal transcatheter mitral valve replacement (TMVR) for use in patients with symptomatic moderate-to-severe mitral ...

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

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 ...

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 ...

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 ...

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 ...