Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions. The corresponding event-free survival rates were 87% and 78%, and freedom from target lesion revascularization was 89% and 82%.
Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months, the company said.
The Zilver PTX Registry study, involving 792 patients from across the world, is assessing the safety and efficacy of the Zilver PTX in treating peripheral arterial disease. In addition to the registry arm of the study, the 480 patient randomized component is designed to evaluate the Zilver PTX across 45 trial sites in the US, Japan and Europe.
Bill Hunter, CEO of Angiotech, said: “We are impressed with both the efficacy and durability demonstrated by the Zilver PTX in the registry study and believe we will see similar results in the US randomized trial which is currently ongoing.
“Our partner, Cook Medical, has been committed to continually improving the efficacy and safety of peripheral DES and early results suggest that the self-expanding, Zilver PTX stent will be an important treatment option for patients with peripheral arterial disease (PAD).”