Tag: Sapien M3

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

IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system […]

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 patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company’s SAPIEN technology, […]