Covidien (COV: Quote) reported the completion of enrollment in its DEFINITIVE Anti-Restenosis or AR study. As the third study in the DEFINITIVE trial series, this randomized pilot is designed to address the challenge of preventing restenosis, a common occurrence in patients with peripheral artery disease or PAD.
According to the American Heart Association, nearly eight million people in the U.S. suffer from PAD, which affects blood vessels throughout the body.
The DEFINITIVE AR trial, a multi-center, randomized study being conducted in Europe, would assess the effect of treating a diseased vessel with a combination therapy that begins with directional atherectomy to remove plaque build-up, followed by the use of a drug-coated balloon that releases anti-proliferative medication to inhibit restenosis. Directional atherectomy is effective in treating PAD without leaving a permanent implant behind, as shown in the DEFINITIVE LE study.
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by RTT Staff Writer
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