FDA has approved the Sapien 3 transcatheter aortic valve for use in aortic stenosis patients deemed to be at "intermediate risk" for open surgery, Edwards Lifesciences announced Thursday. Sapien 3 is the first transcatheter aortic valve in the United States to earn the intermediate-risk indication. The approval was based on data from the PARTNER II trial and as MD+DI previously reported, Sapien 3 valve has shown impressive clinical results. "The clinical outcomes of 1.1 percent mortality ...