In a breakthrough development offering a truly modern, highly effective medical treatment for peripheral arteial disease (PAD), physicians in Europe Monday completed patient implants of the first CE Mark approved drug-eluting stent designed specifically to treat severe blockages in the challenging and largest artery in the leg.
Approval of the polymer-free Zilver® PTX® Drug-Eluting Peripheral Stent from Cook Medical, a world leader in minimally invasive diagnostic and interventional devices, represents a global landmark in effective peripheral intervention for treating PAD, a chronic disease affecting tens of millions of patients worldwide that is a leading cause of leg amputation and shortened lifespans.
Cook’s Zilver PTX is specifically designed and approved to treat PAD affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). It is a self-expanding stent made of nitinol, a space-age 'shape memory' metal that offers unique mechanical advantages for a stent in the SFA.
By eliminating the need for a polymer or plasticizing agent to hold the drug to the stent body, Cook has created a medical breakthrough that solves two key problems. First, it allows targeted delivery of a drug (paclitaxel) proven to reduce the renarrowing (restenosis) of arteries opened using balloon angioplasty. Second, by eliminating the need for a polymer, which was left behind on the body of earlier drug-eluting stents after the drug dissolved into the surrounding tissues, Zilver PTX avoids the potential patient risks posed by leaving a permanent foreign, plastic substance in the body. In addition, the Zilver stent was proven during its clinical trial to be the most durable peripheral stent available, suggesting even greater patient safety, according to the clinical trial data.
The CE Mark follows the world's largest-ever clinical trial for a peripheral stent, led by 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, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated highly positive results. Only 8 percent of all patients with de novo (new) lesions needed a reintervention to reopen the artery in the first 12 months — a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents.
Also, specific patient groups that are often very hard to treat, such as diabetics and patients with in-stent restenosis (those treated previously with a noncoated stent), were shown in the trial to benefit from the Zilver PTX. As the trial data indicate, the superior results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50 percent and 75 percent, an important patient benefit.
The awarding of the CE Mark is set to herald a revolution in the treatment of peripheral arterial disease,” comments Dr. Michael Dake. “This global study proves that the Zilver PTX has the integrity, safety and durability needed to successfully address many of the well-known limitations of current treatments for the management of PAD.
Rob Lyles, global leader and vice president of Cook Medical's Peripheral Intervention division states, “We've specifically designed the Zilver PTX to be safer and more effective for PAD patients by engineering this device for the unique demands of treating this disease in the SFA. It's polymer free, it's fracture resistant, and through the largest trial of its nature in history, it's been clinically proven to be significantly more effective in treating peripheral arterial disease in the SFA than other treatment modalities.
“Our unique ability to adhere the drug to the stent without using a polymer is a major clinical advantage. It eliminates the risk some patients may face due to reactions and other potentially poor outcomes that are associated with polymer coatings used on current generations of drug-eluting stents. It's a truly exciting time for Cook Medical and our partners, as well as for physicians and patients alike. With the European launch of this first-of-its-kind 21st century medical technology, we are truly at the vanguard of a revolution in peripheral intervention.”
PAD is one of the fastest-growing and most pervasive diseases of our time, and it is estimated to affect 27 million individuals in Europe and North America, including 8-12 million Americans. Yet, approximately 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 many countries, untreated PAD is the leading cause of leg amputation, and previous treatments such as bypass surgery and the use of angioplasty are much more invasive and/or only have shown only limited long-term success rates.
Following more than 1,200 patients treated worldwide during its clinical evaluation and CE Mark approval on July 24, 2009, the first commercial implantations of the Zilver PTX stent were conducted August 10 in a coordinated effort by physicians in the United Kingdom, Germany, France, Holland, Belgium, Sweden, Switzerland and Spain. In the United States, the Zilver PTX drug-eluting stent is an investigational device not available for sale.
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 radiology; critical care medicine; gastroenterology; peripheral vascular medicine; bone access and oncology; interventional cardiology; general 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.