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Zilver PTX Stent is used for the first time outside the heart by Japanese surgeons

Cook : 11 July, 2007  (New Product)
A drug coated stent designed to prevent blockages in the leg artery has been used for the first time in Japan, for use outside the heart, by Dr Takao Ohki, chairman, Department of Surgery, professor and chief, Department of Vascular Surgery at Jikei University Hospital in Tokyo, Japan.
The surgery was part of the international Zilver PTX Stent Trial sponsored by Cook Medical.

The Zilver PTX Drug-Eluting Stent trial is intended to determine if the same type of drug-eluting technology found in popular drug-coated stents used to treat blockages in the coronary arteries can be used to treat blockages in arteries outside the heart.

'Drug-coated stents that combine a metal scaffold to hold open an artery with a drug to prevent renarrowing have been one of the most successful treatments for coronary artery disease over the last 6 years, and now we hope to bring similar benefits to patients suffering peripheral artery disease (ASO),' explained Dr Ohki. 'This is a severely under-diagnosed and under-treated condition in Japan, and devices such as the Zilver PTX Stent hold great promise for patients suffering from this disease.'

In addition, this is the first medical trial ever conducted simultaneously in the USA and Japan, Cook officials reported. The Japanese trial is being conducted at the following four locations with the following four principal investigators listed in alphabetical order: Dr Hiroyoshi Yokoi, Kokura Memorial Hospital; Dr Kimihiko Kichikawa, Nara Medical University; Dr Takeshi Kimura, Kyoto Medical University and Jikei University Hospital.

Clinical data collected on Japanese and US patients will be combined for the final evaluation of the safety and effectiveness of the device and be used for regulatory submissions in both markets for approval to sell the Stent commercially. Traditionally submission in Japan has been submitted several years later than in the USA and has led to the so called ‘device lag’ problem.

'Bringing together converging technologies, like medical devices coated with pharmaceuticals in the case of Zilver PTX, is a critical step in developing new advanced medical therapies to treat many particular patient populations,' added Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention division that is conducting the groundbreaking medical study. 'At Cook, we continuously strive to produce even more effective, innovative medical products and in turn, improve the quality of health for our patients.'

Peripheral artery disease (PAD or ASO) affects blood vessels that lead from the heart to other areas of the body, such as the legs, feet and kidneys. When these blood vessels become blocked due to the build-up of fatty deposits, blood circulation can be restricted. If it goes untreated, PAD can result in pain when walking and can lead to gangrene and amputation. PAD is a serious medical condition that affects millions of patients worldwide each year.

The Zilver PTX, a self-expanding nitinol stent, is designed by Cook Medical to prevent blockages in the femoropopliteal artery (the major artery in the thigh) above the knee after angioplasty. The stent, a small metal device that acts as a scaffold, props open the blocked artery while the paclitaxel is intended to reduce inflammation and inhibit scar tissue formation that can cause the artery to become blocked.

The Zilver PTX uses a proprietary polymer-free coating technology to coat the Stent with paclitaxel, a drug that has been used successfully to reduce the risk of re-narrowing of arteries in the heart. In many cases, PAD patients who have been treated with balloon angioplasty and stenting experience restenosis, or re-narrowing of the arteries, over time and must undergo more invasive treatment such as bypass surgery to reopen the arteries.
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