Boston Scientific (NYSE:BSX) said it’s launched a post-market registry study for its Lotus replacement heart valve, aiming to follow patients implanted with the transcatheter aortic heart valve out to 5 years.
The Respond registry is slated to enroll 1,000 patients at 50 centers worldwide, according to a press release. Three patients have already been enrolled in the trial, a prospective, open label, single arm, multi-center, observational post market study, Boston Scientific said.
The study will track patients at discharge, 30 days, 12 months and annually through 5 years, according to the release, with a primary endpoint of all-cause mortality compared to a performance goal.
"An independent core laboratory will analyze the echocardiographic images and an independent clinical events committee will adjudicate key clinical events. These measures are designed to increase the quality of the collected data and address inconsistencies with site-reported data commonly observed in post market studies," the Natick, Mass.-based medical device company said.
"The Lotus valve system functions early and allows for precise valve placement without the need for temporary pacing during deployment," chief medical officer Dr. Keith Dawkins said in prepared remarks. "Differentiated features include an adaptive seal that minimizes paravalvular leakage, which was confirmed in the results of the Reprise clinical program."
Boston Scientific won CE Mark approval in the European Union for the Lotus device in October 2013.