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news.Angiotech Pharmaceuticals's corporate partner, Cook Medical, has reported positive interim results from the registry arm of a clinical study measuring the effectiveness of its Zilver PTX drug-eluting peripheral stent in treating peripheral arterial disease.
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The company said that the results revealed clinical improvement, excellent durability and fracture resistance, and high rates of event-free survival (EFS) and freedom from target lesion revascularization (TLR). In addition, the Zilver stent exhibited no safety concerns and results were better than expected for TASC class C and D lesions, occlusions, in-stent restenosis and lesions greater than 7cm (2.75 inches).
Interim data was compiled at six and 12 months using 435 patients and 200 patients, respectively. The corresponding EFS rates were 94% and 84%, and freedom from TLR was 96% and 88%. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six months that was maintained through 12 months.
Follow-up to the registry arm of the study will continue through two years.
Under the terms of its 1997 license agreement with Cook, Angiotech is entitled to receive royalty payments upon the commercial sale of paclitaxel-eluting peripheral vascular stent products, including the Zilver PTX.
William Hunter, president and CEO of Angiotech, said: “We are hopeful that Cook will encounter similarly positive results throughout the duration of the Zilver PTX trial and we are excited about the potential benefits the Zilver PTX stent may provide patients suffering from peripheral arterial disease.”