Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability

Edwards Lifesciences today 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.

“Today’s patients are living longer, more active lives, with high expectations for their health and quality of life, so lifetime management of heart valve disease, starting with the first valve, is increasingly important,” said Flavio Ribichini, professor of cardiovascular medicine at the University of Verona. “SAPIEN 3 Ultra RESILIA gives these patients a promising option, as RESILIA tissue’s calcium-blocking technology addresses structural valve deterioration, one of the primary causes of reintervention following heart valve replacement.”

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%).^‡

“RESILIA tissue is the result of nearly 20 years of research and development and is a prime example of Edwards’ continued focus on delivering technology that puts patients first​,” said Gregory Servotte, senior vice president of transcatheter heart valves EU at Edwards Lifesciences. “Latest data emphasize the value of RESILIA tissue in the lifetime management of valve disease.^‡§ The SAPIEN 3 Ultra RESILIA valve utilizes this technology with the aim of improving quality of life, offering sustainable long-term patient outcomes and making future treatment options possible.”