Boston Scientific Corp. (BSX) announced positive results from a pre-specified analysis of the first 60 patients enrolled in the REPRISE II trial evaluating the performance and safety of the Lotus Valve System in symptomatic patients with severe aortic valve disease considered at high risk for surgical valve replacement.
The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind with an Adaptive Seal that is designed to minimize aortic regurgitation (leaking) and is both fully repositionable and retrievable prior to release.
The data demonstrated that the Lotus Valve System met the primary performance endpoint for the first 60-patient cohort and was implanted successfully in all patients (60/60 patients) with no case of severe paravalvular regurgitation.
REPRISE II is an ongoing prospective, single-arm study that has completed enrollment of 120 patients at fourteen sites in Australia, France, Germany and the United Kingdom. All patients had severe symptomatic aortic stenosis and were considered at high risk for surgical valve replacement.
REPRISE II is being extended to enroll an additional 130 patients at twenty sites in Australia and Europe.
According to the company, the primary device performance endpoint was met as the 30-day mean aortic valve pressure gradient of 11.28+5.23 mmHg with a one-sided upper confidence bound of 13.09 was significantly less (P<0.0001) than the performance goal of 18 mmHg. The primary safety endpoint, defined as all-cause mortality at 30 days, was 1.7 percent.
The company said no instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
The company expects the results of the REPRISE trials to be used to support CE mark and other international regulatory approvals.
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