Medical Design & Outsourcing

ePTFE might be the next nitinol-like medtech material

Implants like stents, stent grafts and replacement heart valves often combine ePTFE (expanded polytetrafluoroethylene) with ...

AI Diagnostics: The End of the High-Cost Imaging Era

The coverage milestone follows the American Medical Association's implementation of new Category I CPT payment code 75577 for Heartflow Plaque Analysis effective January 1, 2026. Heartflow Plaque ...
Orange County Business Journal

Edwards Sapien M3 Valve Gets FDA Approval

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 ...
Seeking Alpha

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 transcatheter mitral valve replacement (TMVR) system for patients with mitral ...
Nasdaq

Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System Wins FDA Approval

(RTTNews) - Edwards Lifesciences Corp. (EW) on Tuesday said its SAPIEN M3 mitral valve replacement system received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral ...
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 ...
The Bakersfield Californian

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 transcatheter therapy utilizing a transseptal approach to receive U.S. Food and ...
MD&M East

Edwards Secures US-First Approval for Mitral Regurgitation Treatment

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 ...
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 ...