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 ...

(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 ...

Irvine-based Edwards Lifesciences Corp. on Thursday posted a slightly higher second-quarter profit as growing sales of its heart valves offset higher costs. Edwards also offered a conservative outlook ...

The proposed Medicare coverage change could help Edwards Lifesciences gain market share from Medtronic and Boston Scientific, ...

EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial SAN FRANCISCO--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced data demonstrating successful patient ...

“Building on a year in 2025 marked by solid financial performance and strategic progress, we delivered another strong quarter in Q1, achieving 12.7% sales growth, which reflects the impact and ...

Edwards Lifesciences (EW) announced its SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive FDA approval for the treatment of ...

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 ...

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 ...