U.S. pivotal trial of Self-Expanding Transcatheter Heart Valve has commenced.  The news was reported by Edwards Lifesciences Corporation (NYSE: EW).

The prospective, single-arm, multi-center 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 reports the company.

Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves said, “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.” He added, “We look forward to demonstrating the safety and effectiveness of this advanced transcatheter system.”

Separately, 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 CENTERA’s delivery system.

The CENTERA valve was approved in Europe in February 2018 for the treatment of high-risk patients suffering from severe, symptomatic AS. The CENTERA valve is not approved for commercial sale in the U.S.

The Edwards CENTERA valve can be delivered through a low-profile, 14-French, motorized delivery system. It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.