FDA Asked to Review Peripheral Drug-Eluting Stent


June 14, 2010

June 14, 2010 – A self-expanding, polymer-free, drug-eluting peripheral stent has been submitted for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA). Cook Medical submitted the PMA for its Zilver PTX Drug-Eluting stent, which is intended for use in the superficial femoral artery (SFA).

Filing for premarket approval with the FDA is a step toward bringing the stent to market in the United States. The 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 peripheral artery disease (PAD) in the 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 8 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. He is 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.”

For more information: www.cookmedical.com