Edwards Lifesciences has commenced the US pivotal trial that will study its self-expanding Centera transcatheter aortic valve implantation (TAVI) device for severe, symptomatic aortic stenosis patients at intermediate risk of open-heart surgery. The prospective, single-arm, multicentre study is expected to enrol approximately 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.
Separately, in a press release, Edwards confirmed 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 the valve’s delivery system. The valve was approved in Europe in February 2018 for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. It is not approved for commercial sale in the USA.
Larry L Wood, Edwards’ corporate vice president, transcatheter heart valves, comments: “We are pleased to launch this rigorous study, which we believe will build a robust body of evidence to support the use of this feature-rich, self-expanding valve system in the treatment of patients with aortic stenosis. We look forward to demonstrating the safety and effectiveness of this advanced transcatheter system.”
The Edwards Centera valve can be delivered through a low-profile, 14Fr, motorised delivery system. It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.