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 ...

FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first ...
Medical Device and Diagnostic Industry (MD+DI)

Edwards Secures US-First Approval for Mitral Regurgitation Treatment

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

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 ...
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.
TCTMD

FDA Approves Sapien M3 for Transseptal Mitral Valve Replacement

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 ...
Fierce Biotech

Edwards nets FDA approval for Sapien M3 transcatheter mitral valve replacement

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

Edwards Lifesciences receives FDA approval for SAPIEN M3 mitral valve system

Edwards Lifesciences (EW) announced its SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal ...
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 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 ...