PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports 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), a proven predictor of mortality, and is both fully repositionable and retrievable prior to release. Data were presented today as a late-breaking clinical trial at the EuroPCR Scientific Program in Paris by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. 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.
- 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.
- Independent core lab assessment of paravalvular aortic regurgitation at 30 days indicated no severe regurgitation and one case of moderate regurgitation (1.9 percent). In 79.2 percent of patients there was trace or no paravalvular regurgitation at 30 days.
- No instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
"The ability to initially position the Lotus valve very precisely and, if needed, to easily reposition or indeed fully retrieve the valve provide the operator with remarkable control," said Professor Meredith. "When combined with immediate and near complete elimination of aortic regurgitation, even in patients who began with moderate or severe aortic regurgitation, the results are impressive and reflect very favorably on the unique features of the Lotus technology."