Business Wire

Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrates Continued Excellent Outcomes for Patients in Real World Data

LONDON--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented ...
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) ...
Nasdaq

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 ...
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 ...

Edwards’ Structural Heart Leadership Demonstrated Through Expanding Body of Scientific Evidence at New York Valves

Edwards Lifesciences (NYSE: EW) today announced new data presented at New York Valves 2026, the annual conference organized by the Cardiovascular Research Foundation, which reinforce the company's ...

Edwards Lifesciences stands out as US agency eyes broader access for heart valve device

On Monday, the Centers for Medicare & Medicaid Services (CMS) proposed removing the coverage with evidence development (CED) ...
RAPS

Edwards Recalls Part of Transcatheter Heart System After One Death

Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the ...
RAPS

FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high ...
Reuters

FDA to review new Edwards heart valve in July

CHICAGO (Reuters) - Edwards Lifesciences Corp said a U.S. regulatory advisory panel will review on July 20 its application to sell a replacement heart valve that spares patients the need for ...
Orange County Business Journal

Edwards Up on Heart Valve Studies

Irvine-based Edwards Lifesciences Corp.’s shares rose today on positive results from several studies of less-invasive heart valves. The company’s shares closed up 10% today to a market value of $16 ...
Reuters

Redesigned Edwards heart valve system shows improvement in study

SAN FRANCISCO, March 10 (Reuters) - A smaller, redesigned version of Edwards Lifesciences' non-invasive heart valve replacement system called Sapien XT performed well and led to fewer complications ...