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COLORADO SPRINGS, Colo., Feb. 24, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced that the EXCITE ISR trial achieved the statistical endpoints of the adjunct analysis. The trial evaluates laser atherectomy plus Percutaneous Transluminal Angioplasty (PTA) compared with PTA alone for the treatment of in-stent restenosis (ISR) in patients suffering from peripheral artery disease (PAD).
The company anticipates submitting the 510(k) application to the FDA in the next 45 days. FDA review of a 510(k) application with clinical data takes an average of five months.
The EXCITE adjunct analysis, which was approved by the FDA in May 2013, allowed for multiple interim data analyses during the randomized trial. Statistical success was achieved based on enrollment of 250 patients at 35 sites across the U.S.
Spectranetics designed this treatment-to-control trial to show safety and effectiveness of treatment with laser atherectomy. Freedom from target lesion revascularization (TLR) at six months was hypothesized to be 70% in the laser atherectomy plus PTA arm and 53% for PTA alone to prove statistical superiority. This benchmark was exceeded, which demonstrated early success.
"This is an important milestone for our company and for patients worldwide," said Scott Drake, President and Chief Executive Officer. "Patients who suffer from PAD and the physicians who treat them deserve a proven, durable treatment algorithm. Keys to unlocking this $750M market opportunity include obtaining the ISR indication, practice-changing clinical data and excellent commercial execution. Our primary competitors are contraindicated for ISR, making us uniquely positioned on all fronts."
According to Dr. Eric J. Dippel M.D., Genesis Medical Center, Iowa, and primary investigator, "EXCITE is a landmark randomized, controlled trial that represents a major step forward in treating patients with ISR. This is a very large patient population that has suffered from insufficient, unproven treatment for too long."