Edwards Lifesciences基于AMPS M3、EVOQUE瓣膜置换的数据

2025-10-28 03:51

Edwards Lifesciences (NYSE:EW) is up ~7% in Monday trading after releasing new data on its SAPIEN M3 and EVOQUE heart valve replacement systems.
Results from the ENCIRCLE trial of SAPIEN M3, a transfemoral transcatheter mitral valve replacement (TMVR) system, showed low heart failure hospitalization and death rates, as well as significant mitral regurgitation elimination.
Thirty-day data from the EVOQUE system STS/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, found lower pacemaker rates (14.9%) and minimal major or life-threatening bleeding rates (1.3%) at 30 days compared to the TRISCEND II pivotal trial that read out in October 2024.
While EVOQUE is approved in the US, SAPIEN M3 is still awaiting US FDA clearance.

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