The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

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 ...

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

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

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 ...

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 ...

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 ...

Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking the agency’s first in this type of implant that takes a potentiall | The ...

IRVINE, CA. -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received conditional Investigational Device ...