Edwards Lifesciences announced it received approval from the U.S. Food and Drug Administration (FDA) for the Mitris Resilia valve, a tissue valve replacement specifically designed for the heart's mitral position.

The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It also features a low-profile frame that helps avoid obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy, to facilitate potential future transcatheter interventions for patients. This therapy is the company's latest innovation offering advanced Resilia tissue with an anti-calcification technology that also allows devices to be stored under dry packaging conditions, facilitating ease of use.

Resilia tissue is bovine pericardial tissue and serves as the platform for Edwards' new class of valves. Resilia tissue has been studied in two robust pre-market clinical trials, as follows: (i) the COMMENCE trial comprised of 694 patients enrolled in an aortic arm who were followed for five years, some of whom will be followed for 10 years, and 83 patients enrolled in a mitral arm who were followed for five years, some of whom will be followed for 10 years, and (ii) the EU Feasibility trial comprised of 133 patients enrolled who were followed for five years. These studies together represent outcomes on 904 patients and more than 3,800 patient years of follow-up.

"For patients who need mitral valve replacement, the advanced Mitris Resilia valve is based on a trusted pericardial valve platform, designed to mimic the native valve and incorporating tissue with integrity-preservation technology that will potentially allow the valve to last longer," said Kevin Accola, M.D., Cardiovascular Surgeon, AdventHealth Orlando.

"Mitral valve disease is prevalent, and the patients impacted experience the disease in variable ways," said Daveen Chopra, Edwards' corporate vice president, surgical structural heart. "It was important to design the valve to perform like the native mitral valve, handling the highest pressures in the heart and offering sustained hemodynamic performance, so that surgeons and patients can have confidence in this new therapy option."