March 7, 2014 — The Spectranetics Corp. 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 U.S. Food and Drug Administration (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 United States.
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 percent in the laser atherectomy plus PTA arm and 53 percent for PTA alone to prove statistical superiority. This benchmark was exceeded, which demonstrated early success.
The Excite ISR trial was designed to enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 treatment to control. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from TLR through six months. The primary safety endpoint is freedom from major adverse events (MAEs) at 30 days. MAEs include all-cause mortality, major amputation in the target limb or TLR. The goal of the adjunct analysis plan was to demonstrate statistically significant clinical superiority of laser atherectomy plus PTA compared with PTA alone prior to full enrollment of the Excite ISR trial.
For more information: www.spectranetics.com