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Zilver® PTX® Stent from Cook Medical Gains CE Mark – Treatment for Peripheral Arterial Disease (PAD)

Posted Aug 12 2009 10:31pm 1 Comment

The stent is coated with paclitaxel, a cancer drug.   The drug lasts in the body for 6-8 weeks, and is used to help prevent infections as well as image decrease the chance of the body rejecting the stent.  Our bodies are designed to heal and regrow tissue, so the drug also helps in that process with keeping excess tissue away from the area where the stent is placed.  The procedure also has less risk for diabetics and those with high blood pressure and can be used for procedures related to hardening of the arteries.  Not too long ago I had a chance to talk with Rob Lyles from Cook Medical and you can read the interview below for additional information.

Cook Medical Interview Discussing PAD Leg Therapies– Rob Lyles, VP Peripheral Intervention Division

“I posed Rob with a scenario, and asked whether I would have the same type of surgery on my leg as my heart if I were a PAD patient.

Rob said that actually, the arteries and veins in the legs are a bit more complex.  Aside from pumping the heart is stationary, whereas the legs are constantly moving.  We can still approach treating the legs in a minimally invasive way though.  With placing a stent in the leg, extra care for durability is a big concern as again, the leg will be moving and the device needs to remain in place and not slip or move.”

This procedure can save legs and potentially avoid amputations, so take a look at this one.

Under the related reading below there’s additional information regarding PAD.  Hopefully with the approval in Europe perhaps the US is not far behind as the clinical trials have done well.  BD

Press Release:

Bjaeverskov, Denmark – August 11, 2009 – In a breakthrough development offering a truly modern, highly effective medical treatment for peripheral arterial 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. image

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 21 st 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 [1], [2], [3], including 8-12 million Americans [4]. 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. clip_image002

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.

Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals, Inc., of Vancouver, British Columbia, Canada ( www.angiotech.com, NASDAQ: ANPI, TSX: ANP).

“Cook is to be congratulated for succeeding where many others have failed in making drug-eluting stent technology a reality for patients with peripheral vascular disease,” said Bill Hunter, Ph.D., president and CEO of Angiotech.  “The Zilver stent platform has shown tremendous durability and performance in clinical trials, and when combined with the proven benefits of paclitaxel in the prevention of restenosis, the Zilver PTX is poised to become the first choice for interventionalists in the management of this common medical condition.”

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.

Media Contact:           Caitlin Watras, Racepoint Group, Inc.

                                    781-487-4632

dave.mccarty@cookmedical.com


[1] Belch JJ, Topol EJ, Agnelli G, et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. 2003;163(8):884–892.

[2] Golomb BA, Dang TT, Criqui MH, et al. Peripheral arterial disease: morbidity and mortality implications. Circulation. 2006;114(7):688–699.

[3] Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic). J Am Coll Cardiol. 2006;47(6):1239–1312.

[4] National Institutes of Health Peripheral Arterial Disease Fact Sheet - NIH Publication No. 06-5837 August 2006

Related Cook Reading:

Cook Medical Announces FDA Clearance for Advance® 35LP PTA Balloon Dilatation Catheter - PVD

Cook Medical Unveils MicroWires to support Leg Therapy - Peripheral Arterial Disease

Cook Medical Contract Gives Access to Health Care Providers through Premier Purchasing Partners to purchase Tissue Repair Products – Regenerative Medicine

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