Edwards Rolls Out Sapien 3 Ultra Resilia TAVR in Europe

Edwards Lifesciences has rolled out its Sapien 3 Ultra Resilia transcatheter aortic heart valve in Europe.
 
The valve recently earned CE mark approval for patients with heart valve disease due to native calcific aortic stenosis at all surgical risk levels due to failure of either a transcatheter or surgical bioprosthetic valve judged to be at high or greater risk for open surgery. Resilia is bovine pericardial tissue with anti-calcification technology that can extend the Sapien 3 Ultra Resilia valve’s durability.
 
The valve was released in the U.S. in 2022 following U.S. Food and Drug Administration approval.
 
“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 VP of transcatheter heart valves EU at Edwards. “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.”

More about Resilia tissue

Resilia tissue is already used in Edwards’ Inspiris Resilia surgical aortic valve. Recent data on Resilia tissue from the company’s seven-year COMMENCE study showed 99.3% freedom from structural valve deterioration, clinically stable gradients, and 97.2% freedom from reoperation.
 
In addition to anti-calcification properties, Resilia tissue can be stored under dry packaging conditions. The Sapien 3 Ultra Resilia valve is currently the only transcatheter heart valve on the market with dry tissue storage.
 
Edwards also recently shared trial results showing excellent paravalvular leak results for the Sapien 3 Ultra Resilia valve, according to its data.