Launch of Sapien 3 Ultra RESILIA valve in Europe with technology to enhance durability – Edwards Lifesciences

Edwards Lifesciences 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.

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%).