Piedmont Heart Institute Leads the East Coast in Transcatheter Mitral Valve Replacement

Piedmont Heart Institute (PHI) physicians Pradeep K. Yadav, M.D., Director of Structural Interventions, and Vinod H. Thourani, M.D., Marcus Chairman of Cardiovascular Surgery, successfully performed ...
Medical Device Network

Edwards receives FDA approval for mitral valve replacement system

Edwards Lifesciences’ SAPIEN M3 Transcatheter Mitral Valve Replacement System. Credit: Edwards Lifesciences/Business Wire. Edwards Lifesciences has received the US Food and Drug Administration (FDA) ...
Investing

Edwards Lifesciences gets FDA approval for SAPIEN M3 mitral valve system

Investing.com -- Edwards Lifesciences has received FDA approval for its SAPIEN M3 mitral valve replacement system, marking a significant advancement in heart valve treatment options. The SAPIEN M3 is ...
Seeking Alpha

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

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach ...
FierceBiotech

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 agency’s first in this type of implant that takes a potentially safer route ...
Investing

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved mitral valve system

IRVINE, California - Edwards Lifesciences (NYSE:EW) has received U.S. Food and Drug Administration approval for its SAPIEN M3 mitral valve replacement system, marking the first transcatheter therapy ...
Healio

Transseptal mitral valve replacement system approved

Please provide your email address to receive an email when new articles are posted on . A transseptal mitral valve replacement system was approved for patients unsuitable for surgery or transcatheter ...
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 ...
medtechdive

Edwards receives FDA approval for mitral valve replacement system

Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday. The device is intended for people with moderate to severe mitral ...
MassDevice

Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy

The Sapien M3 heart valve is anchored in the heart with a catheter-delivered nitinol dock. [Image courtesy of Edwards Lifesciences] Edwards Lifesciences (NYSE: EW) + has won FDA approval for its ...