COLORADO SPRINGS, Colo., March 27, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced early success of the EXCITE ISR clinical trial, achieving highly significant statistical superiority in both safety and efficacy. Notably, this superior outcome was achieved without any borrowing from the PATENT registry. Based on this result, Spectranetics has concluded enrollment in the EXCITE ISR trial and will submit the 510(k) application to the Food and Drug Administration (FDA) today. FDA review of a 510(k) application with clinical data takes an average of five months.
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