Boston Scientific Corporation (NYSE: BSX) announces that it 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 (TAVR) 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.
"We are delighted to complete enrollment in this important trial, and pleased that the clinical results will be presented at the forthcoming EuroPCR conference in Paris next month," said Ian Meredith, Professor and Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE I Trial. "The Lotus Aortic Valve System offers the unique ability to precisely position the valve during deployment with the added ability to reposition and retrieve the device if necessary. The valve functions remarkably early in the deployment process, offering interventional cardiologists greater control over the deployment. We observed virtually no aortic regurgitation in all cases immediately after implantation."
The primary endpoint of the REPRISE I trial is defined as clinical procedural success without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or seven days post-procedure (whichever comes first). In-hospital MACCE includes death, heart attack, major stroke, and conversion to surgery or repeat procedure due to valve-related dysfunction. Secondary endpoints under study include successful repositioning of the Lotus Valve System (if attempted) and incidence of aortic valve regurgitation (leaking).