Irvine, Calif.-based Edwards Lifesciences Corp. reported the start of its U.S. pivotal trial evaluating the self-expanding Centera transcatheter valve for severe, symptomatic aortic stenosis patients at intermediate risk of open-heart surgery. The prospective, single-arm, multicenter study is expected to enroll about 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at one year. Read More
