Miami, Fla. – An investigational drug-eluting stent (DES) from Cook Medical showed sustained primary patency at two years compared to data collected at one year in the device’s prospective, randomized study, according to data presented today at the ISET 2010 International Symposium on Endovascular Therapy. The data, compiled from 479 patients enrolled in a randomized controlled trial being conducted to obtain U.S. Food and Drug Administration PMA clearance for the device, showed that patients receiving the self-expanding nitinol stent, which is coated with the drug paclitaxel, had 83.1 percent primary patency after 12 months. When evaluated at 24 months, the patency rate for the 278 patients tested from that cohort was 74.8 percent.
The two-year results were presented by Michael Dake, M.D., the trial’s principal investigator and medical director of the Cath/Angio Laboratories at Stanford University School of Medicine.
Data from the multicenter, prospective trial also show the Cook DES achieved 86.6 percent event-free survival at 24-months.
“This clinical trial was rigorously designed to lend real-world perspective to the current treatment landscape of PAD, and we are excited by the results we have thus far collected,” said Rob Lyles, global leader and vice president of Cook Medical’s Peripheral Intervention division. “At Cook, we’re committed to delivering technologies that advance minimally invasive health care for as wide a patient population as possible.”
PAD, also called “hardening” of the arteries or atherosclerosis, occurs when fatty deposits and inflammation reduce the blood supply to the extremities. PAD occurs in as many as one in five Americans over the age of 65, yet just a quarter of those receive treatment1.
The world’s largest study of its kind, the randomized trial is complemented by a global single-arm registry involving 787 patients, including diabetics, symptomatic patients and those with complex lesions. The Zilver PTX Drug Eluting Stent is an investigational device not approved for sale in the United States.
About the International Symposium on Endovascular Therapy (ISET):
Now in its 21st year, the leader in interventional education continues to meet the needs of physicians who recognize the challenges that lie ahead and actively seek the knowledge to meet those challenges. ISET provides the tools – in the form of unbiased, professional education – to lead practitioners into the future of an ever-evolving field. For more information, visit www.iset.org.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @cookvascular.
1American Heart Association Peripheral Arterial Disease Statistical Fact Sheet: http://www.americanheart.org/downloadable/heart/1198011637413FS26PAD08.REVdoc.pdf