Spectranetics Corporation (Nasdaq:SPNC) today announced six month interim 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. There is no device currently cleared or approved by the FDA to treat peripheral in-stent restenosis, which remains a major unsolved medical problem.
Total enrollment of 90 patients in this prospective, multi-center registry, was completed in December of 2011 at five centers in Germany. Seventy-eight (78) patients have been followed through six months. Interim results presented at LINC 2012 in Leipzig, Germany indicate 76% freedom from target lesion revascularization (TLR) at six months. Notably, the freedom from TLR rate within the PATENT study exceeds the targeted freedom from TLR rate in the randomized controlled EXCITE ISR ( EXCImer Laser Randomized Controlled Study for Treatment of Femoropopli teal In- Stent Restenosis) trial, a landmark study currently underway in the U.S., providing confidence in the EXCITE ISR trial design.
The EXCITE ISR trial will enroll up to 353 patients with chronic peripheral artery disease (PAD) associated with femoropopliteal artery in-stent restenosis at 30 centers in the United States. Patients are randomized in a 2:1 allocation to either laser atherectomy with adjunctive balloon angioplasty or balloon angioplasty alone. The study is designed to show superiority of laser atherectomy plus adjunctive balloon angioplasty for the primary efficacy endpoint of freedom from TLR.
“The PATENT study shows that laser atherectomy for in-stent restenosis lesions can significantly reduce the amount of neointimal hyperplasia with promising TLR rates at six months. We look forward to the twelve month results,” said Dr. Jos Van Den Berg of Ospedale Regionale di Lugano, Lugano Switzerland , who presented the interim results.In the PATENT Study, percent diameter stenosis was reduced from 87.1% to 7.5% post-laser atherectomy and balloon angioplasty as measured by angiographic core lab. Procedural success rate, defined as achievement of ≤ 30% final residual restenosis was 98.8%, 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 at 6 months.
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