Edwards Lifesciences Reports Positive Eight-Year Data on RESILIA Tissue Durability

Edwards Lifesciences announced new eight-year data confirming that aortic surgical valves treated with its proprietary RESILIA tissue offer significantly better long-term durability compared to non-RESILIA bioprosthetic valves.

Presented at the Heart Valve Society Annual Meeting, the study followed 947 patients and showed 99.3% freedom from structural valve deterioration (SVD) in the RESILIA group versus 90.5% in the non-RESILIA group. Freedom from reoperation due to SVD was 99.2% with RESILIA tissue, compared to 93.9% without.

RESILIA tissue is used across a range of Edwards’ platforms, including INSPIRIS RESILIA, KONECT RESILIA, MITRIS RESILIA, and SAPIEN 3 Ultra RESILIA. Over 450,000 patients globally have been treated with these valves.

Company leaders emphasized the data’s implications for reducing reinterventions and improving lifetime management in structural heart disease. The findings build on Edwards' decades-long leadership in heart valve innovation.

For more details, visit [edwards.com](https://www.edwards.com).

Edwards Lifesciences (NYSE: EW) plans to announce its operating results for the quarter ended March 31, 2025 after the market closes on Wednesday April 23, 2025, and will host a conference call at 5:00 p.m. ET that day to discuss those results.

Edwards Lifesciences' SAPIEN M3 Receives CE Mark, Becomes First Transfemoral Mitral Valve Replacement System

Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system has received CE Mark, making it the first transcatheter mitral valve replacement (TMVR) system approved for transfemoral access in Europe. This approval allows use in patients with symptomatic moderate-to-severe or severe mitral regurgitation who are not suitable candidates for surgery or TEER therapy.

The SAPIEN M3 system, based on Edwards’ proven SAPIEN valve platform, consists of a two-step procedure using a novel docking mechanism followed by valve deployment. Delivered through a femoral vein approach, the system minimizes invasiveness and creates a consistent landing zone for the valve.

Clinical data show that the system significantly reduces mitral regurgitation and improves patients’ quality of life. Edwards plans to present results from the ENCIRCLE pivotal trial later in 2025 and conduct a five-year post-market clinical study in Europe.

With this approval, Edwards becomes the only company in Europe offering both transcatheter repair and replacement options for both mitral and tricuspid valves. The SAPIEN M3 system is not yet approved in the United States.