MassDevice

Edwards has new data backing earlier TAVR intervention

Edwards today presented new data at New York Valves 2026 supporting its transcatheter aortic valve replacement (TAVR) ...
TCTMD

Transseptal TMVR in MAC Shows Promise in Registry

Primary results of the ENCIRCLE trial led to approval of the M3 device by the US Food and Drug Administration as the first ...
zacks

New Evidence on SAPIEN 3 Ultra RESILIA Valve Set to Boost EW Stock

Edwards Lifesciences (EW Quick Quote EW - Free Report) has announced one-year, real-world data on its SAPIEN 3 Ultra RESILIA valve at the PCR London Valves 2024. These data add to the extensive body ...
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 ...
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

FDA Panel OK’s Edwards Sapien Heart Valve

A Food and Drug Administration advisory panel on Wednesday cleared a replacement heart valve made by Irvine-based Edwards Lifesciences Corp. for patients too sick to have open-heart surgery. Edwards ...
Business Wire

Edwards SAPIEN 3 TAVR Delivers Proven Long-term Benefits and Valve Performance, New Data Presented at TCT 2025

SAN FRANCISCO--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR. The data ...
zacks

EW Wins FDA Approval for SAPIEN M3 as First Transseptal TMVR Therapy

Edwards Lifesciences won FDA approval for SAPIEN M3, the first transseptal TMVR for mitral regurgitation. EW's system targets patients unable to undergo surgery or edge-to-edge repair by using a ...
Nasdaq

Edwards Lifesciences (EW) Debuts SAPIEN 3 Ultra RESILIA Valve

Edwards Lifesciences Corporation EW recently launched the SAPIEN 3 Ultra RESILIA valve post the FDA approval of the same. The SAPIEN 3 Ultra RESILIA valve comprises the breakthrough RESILIA tissue ...
TCTMD

Economic Analysis Demonstrating Cost Effectiveness of Edwards SAPIEN Valve Presented at ACC

NEW ORLEANS, LA, Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced the results of an economic analysis performed to ...
EurekAlert!

SAPIEN valve, surgery equivalent at 5 years

SAN DIEGO (March 15, 2015) -- Five-year data suggest that the SAPIEN transcatheter heart valve is a feasible option for patients with severe aortic stenosis deemed to be at high risk for open-heart ...