Successful Patient Outcomes Demonstrated With Edwards’ SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025

Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

ENCIRCLE Pivotal Trial Results

One-year outcomes in the ENCIRCLE trial’s main cohort (299 patients unsuitable for other treatment options) achieved low rates for death and low heart failure hospitalization for patients treated with the SAPIEN M3 transfemoral transcatheter mitral valve replacement (TMVR) system. Further, patients receiving the SAPIEN M3 valve therapy achieved substantial mitral regurgitation (MR) elimination (95.7% MR ≤ 0/1+) and significant improvements in symptoms and quality-of-life.

“Mitral regurgitation is highly prevalent. Many patients do not have good treatment options for mitral intervention, and therefore too many are left untreated. These patients often experience symptoms that are life threatening and significantly impact their quality-of-life,” said David Daniels, M.D., Sutter West Bay Medical Group cardiologist, principal investigator and structural heart section chief of Sutter’s Heart & Vascular Service Line. “These ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a very low 30-day mortality in patients receiving a fully percutaneous mitral valve replacement using the SAPIEN M3 system. This is a significant step forward in the treatment of these patients.”

EVOQUE TTVR System STS/ACC TVT Registry Data

With data from 1,034 patients evaluated, findings from the EVOQUE TTVR system STS/ACC TVT Registry demonstrated a positive real-world safety profile across a broad tricuspid patient population. This includes lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at 30 days compared to the TRISCEND II pivotal trial experience. Additionally, almost all patients experienced tricuspid regurgitation (TR) elimination (98% TR ≤ 0/1+) and were discharged to home after a median stay of two days post-procedure.