Edwards Sapien 3 Ultra Resilia Valve Launched in Europe

May 13, 2024—Edwards Lifesciences announced the European launch of the Sapien 3 Ultra Resilia transcatheter aortic heart valve.

Edwards advised that the Sapien 3 Ultra Resilia device recently received CE Mark approval for use in patients with heart valve disease caused by native calcific aortic stenosis at all levels of surgical risk or caused by the failure of either a transcatheter or a surgical bioprosthetic valve and who are judged to be at high or greater risk for open surgical therapy.

According to the company, the device’s Resilia tissue technology is designed to extend the valve’s durability. The bovine pericardial tissue is treated with anticalcification technology that provides the potential to extend the durability of the Sapien 3 Ultra Resilia valve.

Flavio Ribichini, MD, who is a professor of cardiovascular medicine at the University of Verona in Verona, Italy, commented on the device launch in Edwards’ press release.

“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,” stated Prof. Ribichini. “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’ press release advised that Resilia tissue is used in its Inspiris Resilia surgical aortic valve. The company noted that 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 anticalcification properties, Resilia tissue allows the valve to be stored under dry packaging conditions, facilitating ease of use.

Results from a large, real-world study composed of 10,314 patients and based on the United States TVT Registry data 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 at 30 days, lower echo-derived gradients, and larger effective orifice areas across all valve sizes when compared to the Sapien 3 and Sapien 3 Ultra valves.

The data were presented by Curtiss T. Stinis, MD at CRT 2024, the Cardiovascular Research Technologies annual meeting held March 9-12 in Washington, DC, and simultaneously published by Dr. Stinis et al in JACC: Cardiovascular Interventions.