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. It features a low-profile frame for avoiding obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy to facilitate potential future transcatheter interventions.