Cook Medical says one-year follow-up data from its Japanese postmarket surveillance study of the Zilver PTX drug-eluting stent confirms the device’s effectiveness in keeping open the superficial femoral artery.

Of 907 Japanese patients with peripheral artery disease treated with Zilver PTX, 838 were eligible for one-year follow-up. At 12 months, 91.4 percent of those patients did not need target lesion revascularization of the superficial femoral artery, Cook says. The 84.8 percent primary patency result in the postmarket study is similar to results from earlier Zilver PTX studies. Cook announced the results at the 2014 Euro PCR meeting in Paris.

The study — a condition of the device’s 2012 approval by the Pharmaceuticals and Medical Devices Agency — was designed to evaluate Zilver PTX’s performance in real-world patients.

The results build on a 2013 study of patients in the U.S., Germany and Japan that demonstrated 75 percent primary patency in the superficial femoral artery at four years for patients treated with Zilver PTX. The stent received a CE Mark in 2009 and U.S. approval in 2012. — Kellen Owings

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