Cook Medical Stent Becomes First FDA Approved for Peripheral Artery Blockages

The U.S. Food and Drug Administration (FDA) has, for the first time, approved a drug-eluting stent for the treatment of blockages in peripheral arteries. Bloomington, Ind.-based Cook Medical’s Zilver PTX drug-eluting peripheral stent got the nod from the agency, and is already available in various markets outside the United States.

“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “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 U.S. physicians.”

The stent, which is a combination device, is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA). It works by allowing a physician arterial access via the groin, and the stent is then guided down the narrowed artery with a catheter. The stent is deployed and reportedly expands like a scaffold to help keep the artery open after the catheter is withdrawn. The drug paclitaxel, a mitotic inhibitor typically used in cancer chemotherapy, coats the stent, and is taken up by the cells of the arterial wall to help prevent the re-narrowing of the artery over time. The device is made from nitinol, a metal alloy that has shape memory properties.

Cook is making Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters. The products indications for use also allow two Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the United States early in 2013. Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year.

Data from Cook’s clinical trial indicated that eight out of ten patients with Zilver PTX still had open arteries after one year. Only three out of ten patients treated with angioplasty experienced the same. Also, Patients who received a bare metal stent required more than twice as many re-intervention procedures to reopen the SFA as patients who received Zilver PTX, according to the company.

“After conducting the largest randomized controlled study of peripheral stenting ever undertaken, we now see remarkable results in patients treated with Zilver PTX,” said Michael Dake, M.D., 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, Palo Alto, Calif.

“With this approval, treating PAD in the United States will begin to undergo the same revolution that drug elution did for treating coronary artery disease,” added Gary Ansel, M.D., director for 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.”