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 MITRIS RESILIA 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. Edwards is dedicated to partnering with clinicians to develop patient-centric innovations for complex surgical structural heart procedures that improve long-term care and outcomes for patients. The introduction of the MITRIS RESILIA valve completes the portfolio of surgical heart valve innovations incorporating the advanced RESILIA tissue, including an aortic valve, an aortic valved conduit and now a mitral valve.

Edwards continues to invest in innovations in the surgical structural heart field. The MITRIS RESILIA valve is built on the trusted Carpentier-Edwards PERIMOUNT platform, which in 2021, celebrated 40 years of innovative valve replacements for patients. In addition to FDA approval, the MITRIS RESILIA valve has also received regulatory approval in Japan, Canada, and other countries globally.