Boston Scientific has announced the initiation of the RESPOND Post Market Registry to evaluate clinical outcomes in patients implanted with its Lotus valve system, which offers effective treatment for patients with severe aortic stenosis at high risk of surgical valve replacement.
The RESPOND Post Market Registry is an open label, single arm, observational post market study designed to collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centers across the globe.
Clinical follow-up is at discharge, 30 days, one year and annually through five years. The multi-center study has a primary endpoint of all-cause mortality compared to a performance goal, plus secondary endpoints using Valve Academic Research Consortium guidelines and definitions.
As of now, three patients have been enrolled in the RESPOND Registry and they were successfully implanted with the Lotus valve system. The first transcatheter aortic valve implantation (TAVI) procedure has been performed at Erasmus Medical Center in the Netherlands.
The TAVI procedure was performed by using Boston Scientific’s Safari pre-shaped TAVI guidewire, which received FDA clearance and CE Mark in 2013.
The Safari guidewire is designed to facilitate stable, atraumatic valve placement, and is compatible with the Lotus valve system and other TAVI devices.
Boston Scientific global chief medical officer Keith Dawkins said that the Lotus valve system functions early and allows for precise valve placement without the need for temporary pacing during deployment.
"Differentiated features include an Adaptive Seal that minimizes paravalvular leakage, which was confirmed in the results of the REPRISE clinical program," Dawkins added.