Cook Medical is backing a new 200-patient clinical study designed to test a new endovascular treatment. It's structured to address a major complication associated with peripheral artery disease that can lead to leg amputation.
The Bloomington, IN company is sponsoring what is known as the Tibiopedal Access for Crossing Infringuial Artery Occlusions study. As Cook explains, the technique involves gaining access to veins at the foot and then inches wire guides and catheters up the leg, with the goal of reaching blockages in the arteries. Cook says that some surgeons and specific centers have reported some success with the technique, but that it wanted to collect more data in a multicenter study. Clinicians will assess how successful they are in gaining access to veins through the foot and also how successful the procedure is in crossing the lesion.
Peripheral artery disease can lead to critical limb ischemia, where there is a lack of blood flow to the limbs. The condition can lead to critical limb ischemia and leg amputations, and Cook believes the procedure can reduce these by as much as half. Expectations are that 12 sites in the U.S. and Europe will participate. Dr. Craig Walker, who founded and runs the Cardiovascular Institute of the South in Louisiana, will lead the study. According to the company, more than 300,000 people in the U.S. alone suffer from critical limb ischemia each year, with 25% of patients forced to face amputation. And a number of companies are focused on developing drug stem cell and device-related treatment, including Pluristem and Aastrom.
Cook has been focusing on international growth in recent months, with an eye on treating peripheral artery disease. The company last month launched its Zilver PTX drug-eluting stent in Australia, after the family-owned company gained approval for the product in a number of European and other countries (not yet in the U.S.). It is designed to treat PAD in the femoral artery. Cook also looks to Ireland and India as part of its expansion strategy.
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