REPRISE I and II trials to commence for Lotus Aortic Valve System (Boston Scientific)

Boston Scientific has completed enrollment in the REPRISE I clinical trial, which is designed to evaluate the acute safety of the Lotus Aortic Valve System, the first transcatheter aortic valve replacement device of its kind for patients with severe Aortic Valve Stenosis that is both fully repositionable and retrievable prior to release. This prospective, single-arm feasibility study enrolled 11 patients at three sites in Australia. Results from the REPRISE I trial are scheduled to be presented at the EuroPCR Congress in May. Boston Scientific expects to begin enrollment later this year in the REPRISE II study, which is designed to evaluate the safety and performance of the Lotus Aortic Valve System in 120 patients at up to 15 sites in Australia and Europe. Data from the trial will be used to support CE Mark and other international regulatory approvals.