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 I n-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 ≤ 30% final residual restenosis, was 98.9%, and Cumulative Major Adverse Events (MAEs) were 2.2% from procedure through 30 days following the procedure. Patients saw significant and sustained improvement in ankle brachial index (ABI) and walking ability throughout the study. Laser atherectomy in ISR lesions also preserved excellent stent integrity throughout the duration of the study.
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