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Boston Scientific Announces Positive Data From Lotus™ Transcatheter Aortic Valve Trial
Date:5/15/2012

NATICK, Mass., May 15, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces 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 Lotus Aortic Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind that is designed to minimize aortic regurgitation (leaking) and is both fully repositionable and retrievable prior to release.  Data presented today 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.

"Perhaps the most impressive feature of the Lotus Valve System in this study was the ability to precisely position the valve on the first attempt, eliminating the need for repositioning, although this capability was available if needed," said Ian Meredith, Professor and Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE I Trial.  "Another striking feature was that the valve operated early in the deployment process, providing us some comfort and time to consider the valve position, as well as the immediate and almost complete obliteration of aortic regurgitation even in patients who had moderately severe aortic regurgitation after balloon valvuloplasty.  In this regard, I think the Lotus valve technology is somewhat unique."

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 MA
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