Edwards Lifesciences has announced the European launch of the Sapien 3 Ultra Resilia valve, a transcatheter aortic valve incorporating 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 (University of Verona, Verona, Italy). “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, the company says in a press release.
The tissue is already used in the Edwards Inspiris Resilia surgical valve. Recent data on the Resilia tissue from the seven-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 emphasise the value of Resilia tissue in the lifetime management of valve disease. The Sapien 3 Ultra Resilia valve utilises this technology with the aim of improving quality of life, offering sustainable long-term patient outcomes and making future treatment options possible.”
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 Ultra Resilia valve is the only transcatheter heart valve on the market with dry tissue storage.
At Cardiovascular Research Technologies (CRT) 2024 (9–12 March, Wasington, DC, USA), Curtiss Stinis (Scripps Clinic, La Jolla, USA) presented 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 orifice areas across all valve sizes when compared to the Sapien 3 and Sapien 3 Ultra valves.
