Cook Medical Gains US Approval for the Zilver PTX Drug-Eluting Peripheral Stent

November 15, 2012—The US Food and Drug Administration has announced the approval of the Zilver PTX paclitaxel-eluting peripheral stent (Cook Medical, Bloomington, IN). Zilver PTX is the first drug-eluting stent approved for peripheral use in the United States. The device is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA), with approved indications for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.

The approval is supported by data from the Zilver PTX pivotal trial. Key data from the randomized controlled trial include that eight out of 10 patients treated with the device had patent arteries at 12 months compared to only three out of 10 patients treated with angioplasty alone. Patients who received a bare-metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX. The 12-month data were published in Circulation: Cardiovascular Interventions in August 2011, and 24-month data were presented at the International Symposium on Endovascular Therapies (ISET) meeting in January 2011. The 24-month data included 74.8% primary patency in the Zilver PTX group compared to 57.8% for patients treated with angioplasty and bare-metal stents. 

Drs. Michael Dake and Gary Ansel served as principal investigators of the trial and commented on the approval via Cook's announcement.

Dr. Dake, a professor in the Department of Cardiothoracic Surgery at Stanford University School of Medicine and medical director of the Cath/Angio Laboratories at Stanford Medical Center in Palo Alto, California, said, “After conducting the largest randomized controlled study of peripheral stenting ever undertaken, we now see remarkable results in patients treated with Zilver PTX."

“With this approval, treating PAD in the US will begin to undergo the same revolution that drug-elution did for treating coronary artery disease,” added Dr. Ansel, who is the director of the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio, and an assistant clinical professor of medicine in the Department of Internal Medicine at the University of Toledo Medical Center in Toledo, Ohio. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide."

Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division, provided perspective from the company upon news of the landmark approval. “This approval marks the start of Cook’s program to bring the benefits of drug-elution to US physicians treating the peripheral arteries,” he said. “No other company can match Cook’s commitment to this technology, and by the end of 2013 we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to US physicians.”

Cook states that in order to supply Zilver PTX to as many physicians as possible, the device will be launched in a five-step process and initially be available in 80-mm lengths in 6- and 7-mm diameters. The indications for use allow two Zilver PTX 80-mm stents to be overlapped to treat longer lesions up to 140 mm in length. In early 2013, Cook will introduce 40- and 60-mm lengths, which are included in the current approval, to the US market. The company also expects to receive regulatory approval for 120-mm lengths in both diameters next year. Zilver PTX is approved in more than 50 markets worldwide.