First Patient Enrolled in Boston Scientific REPRISE II TAVR Clinical Trial
Boston Scientific (NYSE: BSX) has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus™ Valve System in up to 120 patients with severe aortic valve disease. This international, multi-center study includes 15 sites in Australia, France, Germany and the United Kingdom. The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind that is designed to minimize aortic regurgitation (leaking). The device is both fully repositionable and retrievable prior to release, offering predictable and precise placement. The results of the REPRISE II trial are expected to be used to support CE mark and other international regulatory approvals.
"We were encouraged by the promising results of the REPRISE I clinical trial completed earlier this year and we are therefore very confident about evaluating the safety and performance of the Lotus Valve in a larger patient cohort," said Ian Meredith, Professor and Director of Monash Heart, at Monash Medical Centre in Melbourne, Australia and the principal investigator of the REPRISE II trial. "The Lotus Valve has a number of important