- 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.
Boston Scientific Reports Lotus™ Valve System Met Primary Performance Endpoint In REPRISE II Trial
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