New Study Shows that the Zilver® PTX™ from Cook Medical Effectively Treats Blockages in Critical Thigh Artery
April 7, 2009
London, England, April 7, 2009 – Preliminary data presented today on two-year follow up show that 82 percent of patients who were treated with Cook Medical's Zilver® PTX™ drug-eluting peripheral stent (DES) were free from reintervention at two-year follow up. The Zilver PTX Registry study, involving 792 patients from across the world, is assessing the safety and efficacy of the Zilver PTX in treating PAD. The most recent results were reported at the 31st International Symposium: Charing Cross Controversies Challenges Consensus.
“These results are extremely encouraging as it's the first time paclitaxel-coated stents have been used in the treatment of blockages in arteries outside the heart,” said Zilver PTX global principal investigator, Dr. Michael Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. “Patients treated with the Zilver PTX had a very low complication rate and required fewer reinterventions.”
Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78 percent, and freedom from TLR (target lesion revascularisation) was 89 percent and 82 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months.
Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in the challenging superior femoral artery and popliteal arteries, including behind the knee locations.
One in five in the 65- to 75-year-old age group in the UK1 has peripheral arterial disease (PAD). Yet only a quarter of these people have any symptoms at all. The 'silent' nature of this condition can result in a number of patients being diagnosed only when their condition has progressed to the severe stage. In patients with severe PAD whose condition is not improving with risk-factor modification, exercise programmes and pharmacological therapy, invasive procedures may need to be carried out. These procedures include angioplasty, stenting or surgery.
“We are confident the outstanding results seen in the registry study will be reflected in the randomised Zilver PTX trial which is currently ongoing,” said Rob Lyles, global leader of Cook Medical's Peripheral Intervention products division. “Cook is committed to continually improving the efficacy and safety of our products, with the overall aim of improving patient outcomes. Our clinical research with the self-expanding, polymer-free Zilver PTX stent is demonstrating its potential benefits for patients suffering from PAD.”
In addition to the registry arm of the study, the 480 patient randomised component is designed to evaluate the Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the randomised study, 240 received the Zilver PTX DES. Enrollment in the randomised study was completed in 2008. 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 minimally invasive medical 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. Founded in 1963 and operated as a family-held private corporation, 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.
Sign up here to receive e-mail from Cook on clinical updates, new product details and educational opportunities.
Sign Up »