Edwards Lifesciences Reports Positive Trial Results for SAPIEN M3 and EVOQUE Valve Systems
Edwards Lifesciences Corporation announced positive clinical results for its SAPIEN M3 and EVOQUE valve systems. The ENCIRCLE trial demonstrated that the SAPIEN M3 TMVR system met all safety and effectiveness endpoints, showing low rates of death and heart failure hospitalization. Additionally, the EVOQUE system's 30-day data indicated better outcomes than the TRISCEND II trial. These findings were presented at the TCT 2025 symposium, with the SAPIEN M3 approved in Europe and the EVOQUE system approved in both the US and Europe.
Edwards Lifesciences Corporation announced new clinical data supporting its mitral and tricuspid therapies. One-year results from the ENCIRCLE single-arm pivotal trial, evaluating the SAPIEN M3 transfemoral transcatheter mitral valve replacement (TMVR) system, achieved all primary and secondary endpoints for safety and effectiveness. These outcomes, which include low rates of death and heart failure hospitalization as well as significant reduction in mitral regurgitation, were simultaneously published in The Lancet. Additionally, 30-day data from the EVOQUE system STS/ACC TVT Registry, the largest real-world dataset for transcatheter tricuspid valve replacement (TTVR), showed more favorable outcomes compared to the TRISCEND II pivotal trial. The data were presented during late-breaking sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 symposium. The SAPIEN M3 system is currently approved in Europe as of April 2025, while the EVOQUE system is approved in both the US and Europe. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Edwards Lifesciences Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20251027759798) on October 27, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
