The FDA has approved Edwards Lifesciences' (Irvine, California) Sapien XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from symptomatic aortic stenosis (AS). This is a next-generation, lower-profile system that includes the 29 mm valve size for patients with a large native annulus, which will allow for the treatment of more patients, the company said.