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January 24, 2013
07:14 EDTSPNCFinal results of Spectranetics study supports successful laser atherectomy use
Spectranetics announced final results from the Photo-Ablation using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment, or PATENT, study evaluating the safety and efficacy of the Spectranetics peripheral laser atherectomy catheters for the treatment of in-stent restenosis, or 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, or 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 indicate 82% and 52% freedom from target lesion revascularization, or 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.
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