Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said.
The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint for the study will be a composite of all cause death and/or stroke at one year.
“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,” transcath heart valves corporate VP Larry Wood said in a press release.
Edwards added that it is resuming its commercial introduction of its Centera valve in Europe after completing previously announced minor modifications to its delivery system. The company paused its launch of the device in May.
Earlier this month, a report emerged suggesting that Edwards Lifesciences is looking to open a new facility in Limerick, Ireland, that could bring in up to 600 new jobs for the region.