Cook completes enrollment in international, peripheral DES trial

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Cook Medical has completed enrollment in the first international clinical trial of a drug-eluting stent designed to treat arterial blockages outside the coronary arteries.

The Bloomington, Ind.-based Cook said that the 420 patients enrolled in the randomized trial of its Zilver PTX drug-eluting peripheral stent include peripheral arterial disease (PAD) patients treated in Germany, the U.S. and Japan.

Zilver PTX, a self-expanding nitinol stent, uses a polymer-free technology to coat the device with paclitaxel, an anti-proliferative drug that can been used to reduce the risk of renarrowing of arteries following angioplasty in coronary disease patients, according to Cook.

The company said it has enrolled an additional 780 patients in the European Union, Canada and Korea in a clinical registry to evaluate the safety of its Zilver PTX device. Those data have been used for a submission in Europe for CE Mark marketing approval, with additional regulatory submissions pending in additional markets. The stent has regulatory approval for commercial use in New Zealand, Hong Kong and Singapore, where it has been used to treat patients suffering with PAD.