FDA Approves Edwards’ Mitris Resilia Surgical Mitral Valve

Edwards Lifesciences has received U.S. Food and Drug Administration (FDA) approval for the Mitris Resilia surgical tissue valve replacement for the heart’s mitral position.
 
Mitris Resilia’s saddle-shaped sewing cuff mimic’s the native mitral valves asymmetric shape. Its low-profile frame helps avoid left ventricular outflow tract obstruction by stent posts and is visible under fluoroscopy, helping future transcatheter innovations.
 
Resilia bovine pericardial tissue is the platform for Edwards’ new class of valves. It has been studied in two premarket clinical trials in both the U.S. and Europe. The studies together represent outcomes on 904 patients and over 3,800 patient years of followup once completed.
 
“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,” Kevin Accola, M.D., Cardiovascular Surgeon, AdventHealth Orlando told the press.
 
“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 hemodynamic performance, so that surgeons and patients can have confidence in this new therapy option.”
 
The valve has also earned regulatory nods in Japan, Canada, and other countries globally.