REPRISE 1 trial reports for Lotus Aortic Valve System (Boston Scientific)

The REPRISE I feasibility trial, evaluated the acute safety of the Lotus Aortic Valve System from Boston Scientific, in patients with severe Aortic Valve Disease. Data presented at the annual EuroPCR Scientific Program in Paris demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge. REPRISE I is a prospective, single-arm feasibility study that enrolled 11 patients at three sites in Australia. The primary endpoint is defined as successful device implantation 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. All patients had severe symptomatic Aortic Stenosis and were considered at high risk for surgical valve replacement.No in-hospital MACCE were reported in 91 percent (10 of the 11) of patients. One stroke and no deaths were observed. No moderate or severe paravalvular regurgitation was present after valve placement or at discharge.