Cook Medical has reported 12-month follow-up data from the postmarket surveillance (PMS) study in Japan for its Zilver PTX drug-eluting stent.
The 12-month follow-up data from the Japan PMS study showed that patients who received the Zilver PTX drug-eluting stent showed positive results in keeping open the superficial femoral artery.
The PMS study, which included 907 peripheral arterial disease patients, was designed to evaluate the performance of the Zilver PTX drug-eluting stent in real-world patient use. Of the 907 Japanese patients, 838 were eligible for one-year follow up.
After 12 months, 91.4% of patients in the follow-up group did not need target lesion revascularization of the superficial femoral artery. The 84.8% primary patency result in the PMS study is similar to results from earlier Zilver PTX studies, according to Cook Medical.
Cook Medical Peripheral Interventional division global leader Mark Breedlove said that the company is pleased with the data from the Japan PMS study because the study included a broad range of lesion types and lengths similar to what doctors treat on a daily basis.
"Like our other studies, this evaluation shows that for most patients there is an enduring drug effect from Zilver PTX a year after implantation," Breedlove said.
Cook Medical has received European approval for the Zilver PTX drug-eluting stent in 2009, and the US and Japanese approvals in 2012.
According to Cook Medical, the stent has been used to treat more than 25,000 patients since its release in North America, Europe, Asia, South America, Australia and New Zealand.
Image: Cook Medical’s Zilver PTX drug-eluting stent. Photo: courtesy of Cook Medical.