Edwards Lifesciences has announced it received approval from the US 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.
Resilia tissue is bovine pericardial tissue and serves as the platform for Edwards’ new class of valves, the company said in a press release.
Resilia tissue has been studied in two premarket clinical trials, the COMMENCE trial comprised of 694 patients enrolled in an aortic arm and 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 (AdventHealth, Orlando, USA).
“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 Mitris Resilia valve to perform like the native mitral valve, handling the highest pressures in the heart and offering sustained haemodynamic performance, so that surgeons and patients can have confidence in this new therapy option.”