Edwards Lifesciences Corporation announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company's breakthrough RESILIA tissue technology, designed to extend the valve's durability. Edwards' SAPIEN 3 Ultra RESilIA valve recently received CE Mark+ for use in patients with heart valve disease due to native calcific aortic stenosis at all levels of surgical risk or due to the failure of either a transcatheter or a surgical bioprosthetic valve who are judged to be at high or greater risk for open surgical therapy. Edwards RESILIA is a bovine pericardial tissue treated with advanced anti-calcification technology that provides the potential to extend the durability of the SAPIEN 3 ultra RESILIA valve.

RESILIA tissue is already used in the world's leading surgical aortic valve, the Edwards INSPIRIS RESILIA valve. Recent data on the RESILIA tissue from the 7-year COMMENCE Study showed encouraging results with low rates of structural valve deterioration (99.3% freedom from structural valve deterioration), clinically stable gradients and freedom from reoperation (97.2%). In addition to its anti-calcification properties, RESILIA tissue allows the valve to be stored under dry packaging conditions, facilitating ease of use.

Today, the SAPIEN 3 UltraRESILIA valve is the only transcatheter heart valve on the market with dry tissue storage. At Cardiovascular Research Technologies (CRT) 2024, Dr. Curtiss Stinis presented compelling results from a large, real-world study (10,314 patients), based on US TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. A study of the SAPIen 3 Ultra RESILIA valve found lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger effective oifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves.