Boston Scientific says Lotus system met primary performance endpoint in trial

Boston Scientific reported 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. Data were presented as a late-breaking clinical trial at the EuroPCR Scientific Program in Paris. 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 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. REPRISE II is being extended to enroll an additional 130 patients at twenty sites in Australia and Europe, the company said.

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