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Submitting 510(k) to Food and Drug Administration Today
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.
According to Dr. Eric J. Dippel M.D., Genesis Medical Center, Davenport, Iowa, and primary investigator, "EXCITE is a landmark randomized, controlled trial that represents a major step forward in treating patients with in-stent restenosis. Showing a superior safety and efficacy result early and without borrowing from PATENT is compelling. This superior result was achieved in the most challenging lesion cohort relative to any IDE peripheral study previously conducted."
"We are in the process of developing a new, necessary standard of care for ISR patients. Safety and efficacy superiority are the bedrock of our strategy to unlock this $750 million target market," said Spectranetics President and Chief Executive Officer, Scott Drake. "Early success with EXCITE is another critical step toward our goal of accelerating top line growth, expanding gross margins and achieving meaningful operating leverage."
In-stent restenosis (ISR) occurs when a previously placed stent becomes occluded, or blocked, and is considered to be a challenging condition to treat. Spectranetics designed this treatment-to-control trial to show safety and efficacy of treatment with laser atherectomy in patients with ISR. Freedom from target lesion revascularization (TLR) at six months was hypothesized to be 70% in the laser atherectomy plus Percutaneous Transluminal Angioplasty (PTA) arm and 53% for PTA alone to prove statistical superiority. This benchmark was exceeded following enrollment of 250 patients versus the 318 patients originally planned.