Interim Results for the Zilver PTX Clinical Study from Cook Medical Show Promise for Improving the Treatment of Blockages in the Femoropopliteal Artery
"Cook's registry study and randomized trial are the first to use a paclitaxel-coated stent in the treatment of arterial blockages outside the heart," said Dr. Dake, the trial's global principal investigator. "They are designed to evaluate the safety and effectiveness of DES technology versus percutaneous transluminal angioplasty, and our initial findings in the registry arm give us every reason to believe that Zilver PTX has the integrity, safety and durability needed to successfully address many of the well-known limitations of angioplasty alone for management of PAD."
Interim data was compiled at six and 12 months using 435 patients and 200 patients respectively. The corresponding EFS rates were 94 percent and 84 percent, and freedom from TLR was 96 percent and 88 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six months that was maintained through 12 months.
Evaluation of stent x-rays is ongoing, and currently suggests stent fractures in approximately one percent of cases at six months and less than two percent of cases at 12 months. Follow-up to the registry arm of the study will continue through two years.
"We are quite pleased with this first round of data from the registry portion of the study, and are optimistic we'll encounter similarly positive results throughout the duration of the Zilver PTX trial," said Rob Lyles, global leader of Cook Medical's Peripheral Intervention products division. "At Cook, we are continually driving to improve the quality of our products and, in turn, improve the quality of patient outcomes. We are particularly excited about the potential benefits our self-expanding Zilver PTX stent can provide patients suffering from PAD."
The clinical study is designed to evaluate the Zilver PTX in more than 1000 patients across 31 trial sites in the United States and sites in Asia, Latin America, Canada and Europe. In addition to the 790 DES patients already enrolled in the registry arm of the study, approximately 240 of the 480 patients being enrolled in the randomized arm of the study will have the DES. Ongoing registry follow-up and the results from the randomized study will continue to evaluate the performance of the Zilver PTX Stent. For more information, please visit www.zilverptxtrial.com.
About Cook Medical:
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.
Posted: June 2008