Cook Medical files for PMA of Zilver PTX Drug-Eluting Peripheral Stent with FDA

Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver^® PTX^® Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.

“Cook is committed to continually improving the efficacy and safety of our products with the overall aim of improving patient outcomes.”

Cook's PMA submission includes data from the randomized portion of the ongoing Zilver PTX clinical trial, the largest study of its kind for the endovascular treatment of PAD in the superficial femoral artery (SFA). Encompassing a global single arm registry and a randomized study involving 1,276 total patients including diabetics, symptomatic patients and those with complex lesions, the 479 patients enrolled in the randomized study and the 787 in the single arm study are experiencing clinical improvement, excellent stent durability (i.e., fracture resistance), high rates of event-free survival and freedom from target lesion revascularization. Patency data from the single-arm study was reported at 86.2 percent at 12 months at EuroPCR last month.

"PAD currently affects approximately eight million men and women over the age of 40 in the United States," said Michael Dake, M.D., professor in the Department of Cardiothoracic Surgery at Stanford University Medical School, medical director of the Cath/Angio Laboratories at Stanford University Medical Center and the trial's principal investigator. "The medical community considers percutaneous transluminal angioplasty to be the treatment of choice for patients with PAD, but Zilver PTX shows promise for being a superior method for improving the quality of life of these individuals."

"Filing for pre-market approval with the FDA is an exciting step forward for us in bringing Zilver PTX to market in the United States," said Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention division. "Cook is committed to continually improving the efficacy and safety of our products with the overall aim of improving patient outcomes."

Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals, Inc., of Vancouver, British Columbia, Canada.