By Results Provide Basis for Landmark EXCITE ISR Trial Underway in United States
COLORADO SPRINGS, Colo., Jan. 24, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced final results from the PATENT (Photo-Ablation using the TURBO-Booster® and Excimer Laser for In-Stent Restenosis Treatment) study evaluating the safety and efficacy of the Spectranetics peripheral laser atherectomy catheters for the treatment of in-stent restenosis (ISR) in the femoropopliteal artery in the leg. ISR occurs as a result of narrowing of the artery in patients who have undergone stenting for the treatment of peripheral arterial disease (PAD). There is currently no FDA-cleared or approved device to treat peripheral in-stent restenosis, which remains a major unsolved medical problem.
Ninety patients participated in this prospective, multi-center registry, which completed enrollment in December 2011 at five centers in Germany. The study evaluated extremely complex patients who had a previously failed stent procedure to address peripheral arterial disease.
Final results presented today by Professor Thomas Zeller (Herz-Zentrum Bad Krozingen, Germany) at the Leipzig Interventional Course (LINC) 2013 in Leipzig, Germany, indicate 82% and 52% freedom from target lesion revascularization (TLR) at six and 12 months, respectively. Laser atherectomy demonstrated excellent midterm primary patency of 64% as compared to 37% with balloon angioplasty primary patency as published in previous clinical registries. This is a significant improvement considering the challenging nature of these patients.
In the PATENT Study, percent diameter stenosis was reduced from 87.1% to 7.5% post-laser atherectomy and balloon angioplasty as measured by the angiographic core lab. Procedural success rate, defined as achievement of
