Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system.
Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve.
In addition, it features a low-profile frame for avoiding obstruction of the left ventricular outflow tract by stent posts, and it’s visible under fluoroscopy. The goal was to facilitate potential future transcatheter interventions.
According to a news release, the Mitris Resilia valve represents Edwards’ latest product offering advanced Resilia (bovine pericardial) tissue with an anti-calcification technology allowing devices to be stored under dry packaging conditions for improved ease of use.
Edwards has studied Resilia in two pre-market clinical trials, combining outcomes for a total of 904 patients and more than 3,800 patient years of follow-up that support the tissue replacement platform.
In addition to FDA approval, Edwards’ Mitris Resilia valve has also received regulatory approval in Japan, Canada and other countries worldwide.
“Mitral valve disease is prevalent, and the patients impacted experience the disease in variable ways,” Edwards VP for surgical structural heart Daveen Chopra said in the release. “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.”