Breakthrough drug-eluting stent to treat peripheral artery disease available in Europe

20 August 2009

Surgeons in the UK have completed patient implants of the first CE Mark approved drug-eluting stent designed specifically to treat severe blockages in the largest artery in the leg.

Approval of the polymer-free Zilver PTX Drug-Eluting Peripheral Stent from Cook Medical represents a global landmark in effective peripheral intervention for treating peripheral artery disease (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 plasticising 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 collected in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada, and Korea and demonstrated highly positive results. Only 8 per cent of 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 trials published, the Zilver PTX stent showed a reduction in re-intervention of between 50 per cent and 75 per cent, 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."

About peripheral artery disease (PAD)

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 America1,2,3. 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 24 July 2009, the first commercial implantations of the Zilver PTX stent were conducted on 10 August 2009 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.

In the UK Dr. Nick Chalmers from the Manchester Royal Infirmary participated in the first commercial use.

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