Edwards Commences United States Pivotal Trial of Centera Transcatheter Heart Valve
October 8, 2018—Edwards Lifesciences announced that it has commenced the United States pivotal trial of its self-expanding Centera transcatheter valve for severe, symptomatic aortic stenosis in patients who are at intermediate risk for open heart surgery. The prospective, single-arm, multicenter study is expected to enroll approximately 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at 1 year.
Separately, Edwards confirmed that it has updated its regulatory filings and is now resuming the commercial introduction of the Centera valve in Europe after completing the previously announced minor modification to Centera's delivery system. The Centera valve was approved in Europe in February 2018 for the treatment of high-risk patients with severe, symptomatic aortic stenosis.
The Centera valve can be delivered through a low-profile 14-F motorized delivery system. It is packaged with the valve fully preattached to the delivery system to facilitate simple and rapid device preparation. The device is not approved for commercial sale in the United States, advised Edwards Lifesciences.