WASHINGTON (dpa-AFX) - Boston Scientific Corp. (BSX) announced results from the REPRISE I feasibility trial, which evaluated the acute safety of the Lotus Aortic Valve System in patients with severe aortic valve disease.
The company stated that the Lotus Aortic Valve System is the first transcatheter aortic valve replacement or TAVR device of its kind that is designed to minimize aortic regurgitation (leaking) and is both fully repositionable and retrievable prior to release.
The company said the data 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 or 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, the company said.
'We look forward to advancing the Lotus Aortic Valve System clinical program by initiating patient enrollment in the REPRISE II study later this year, ' said Keith Dawkins, M.D., global chief medical officer for Boston Scientific.
The REPRISE II trial 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 are expected to be used to support CE Mark and other international regulatory approvals. Enrollment is expected to be completed in the first half of 2013.
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