June 16, 2014 — Boston Scientific Corp. has initiated the RESPOND post-market registry to assess real-world performance of the Lotus valve system. The RESPOND registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centers around the world.
Three patients enrolled in the RESPOND registry thus far have been successfully implanted with the Lotus system. Nicolas Van Mieghem, M.D., and Peter De Jaegere, M.D., Ph.D., led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Center in Rotterdam, the Netherlands, using the Boston Scientific Safari pre-shaped TAVI guidewire, which received U.S. Food and Drug Administration (FDA) clearance and CE mark in 2013 and is designed to facilitate stable, atraumatic valve placement.
The RESPOND registry is a prospective, open label, single-arm, multicenter, observational post-market study. Clinical follow-up is at discharge, 30 days, 12 months and annually through five years. It features a primary endpoint of all-cause mortality compared to a performance goal, plus secondary endpoints using Valve Academic Research Consortium guidelines and definitions. 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.
"It's a great privilege to kick off the RESPOND registry with this first implant," said Van Mieghem, co-lead principal investigator. "The Lotus valve system truly is an elegant and novel transcatheter valve concept providing a high level of precision and control. It simplifies the TAVI procedure by having the ability to assess valve functionality fully before release, which helps ensure optimal valve placement and a positive clinical outcome."
The Lotus valve offers a unique and effective treatment for patients with severe aortic stenosis at high risk of surgical valve replacement. It is a next-generation TAVI device designed to give physicians total control throughout the TAVI procedure.
"The Lotus valve system functions early and allows for precise valve placement without the need for temporary pacing during deployment," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "Differentiated features include an Adaptive Seal that minimizes paravalvular leakage, which was confirmed in the results of the REPRISE clinical program."
REPRISE II six-month outcomes were presented at EuroPCR 2014 in Paris. The clinical study demonstrated that the Lotus valve system delivered sustained safety and effectiveness outcomes out to six months, with only 1.1 percent of patients having moderate paravalvular aortic regurgitation (leaking). No severe cases occurred. REPRISE II is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.
For more information: www.bostonscientific.com