May 15, 2013 — The Spectranetics Corporation announced the U.S. Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty (PTA) compared with PTA alone, prior to full enrollment of the EXCITE ISR study.
Spectranetics' adjunct analysis plan incorporates multiple interim data analyses of patients enrolled in the ongoing EXCITE ISR trial, with the potential to leverage data from the recently completed PATENT trial. The plan allows for six-month follow-up to be completed in a subset of patients.
The primary endpoints of the EXCITE ISR trial, freedom from target lesion revascularization (TLR) through six months and freedom from major adverse events (MAEs) at 30 days, remain unchanged. MAE includes all-cause mortality, major amputation in the target limb or TLR.
"We are pleased to have achieved this meaningful step toward FDA approval of our therapy to treat in-stent restenosis," said Scott Drake, president and chief executive officer. "The adjunct analysis provides a potentially streamlined path for improving patients' lives and capitalizing on this transformative global market opportunity, which we estimate at 250,000 procedures annually. We continue to target mid-2014 for commercialization of the ISR indication. Our commitment to prove clinical superiority over PTA treatment alone in ISR patients is steadfast. Today, we are focused on completion of the EXCITE ISR trial and, in the future, we believe our ongoing PHOTOPAC study will show that laser atherectomy combined with drug-coated balloons is a next generation ISR treatment."
"The approval of the adjunct analysis underscores the need for proven technologies to treat patients with in-stent restenosis. Today, these patients are largely treated using PTA alone with suboptimal clinical outcomes. No device on the market has the ISR indication and successful completion of the EXCITE ISR trial will address a large, unmet clinical need for more durable outcomes in this difficult patient population," stated Eric Dippel, lead physician investigator for EXCITE ISR.
For more information: visit www.spectranetics.com