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 ...

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 ...

WASHINGTON -- A slight tweak to the Sapien 3 turned it into a device usable for transcatheter mitral valve replacement (TMVR), a first-in-human experience showed. By adding a new sealing skirt, ...

Edwards Lifesciences Corp. today announced that it received CE Mark approval, the European equivalent of the Food and Drug Administration, for its Sapien M3 mitral replacement system. The device ...

Edwards Lifesciences has received Europe’s CE mark for its transcatheter mitral valve replacement system, Sapien M3, the company said Monday. The device is designed for people with symptomatic mitral ...

SAN FRANCISCO -- For selected patients with mitral regurgitation (MR), the Sapien M3 device delivered highly promising 1-year outcomes for the desperate field of transcatheter mitral valve replacement ...

Edwards Lifesciences’ SAPIEN M3 mitral valve replacement system has become the first transcatheter therapy utilizing a transseptal approach to snag FDA approval in the U.S. for the treatment of mitral ...

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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 ...

The FDA has approved Edwards Lifesciences Corp.’s Sapien M3 transcatheter mitral valve replacement system. The U.S. approval, announced last week, comes eight months after the device received CE Mark ...