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

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

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

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. 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 ...

One-year outcomes in the ENCIRCLE trial’s main cohort (299 patients unsuitable for other treatment options) achieved low rates for death and low heart failure hospitalization for patients treated with ...

SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR. The ...

SAPIEN 3, which showed superiority at 1 year, also demonstrates compelling outcomes equivalent to surgery at seven years SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced ...

Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm ...