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Covidien (NYSE:COV), a leading global provider of healthcare products, today announced the completion of enrollment in its DEFINITIVE AR (Anti-Restenosis) study. As the third study in the DEFINITIVE trial series, this randomized pilot is designed to address the challenge of preventing restenosis (re-narrowing of a blood vessel following treatment), a common occurrence in patients with peripheral artery disease (PAD).
According to the American Heart Association, approximately eight million people in the U.S. suffer from PAD.
1 PAD affects blood vessels throughout the body. When the vessels become clogged with plaque, blood flow slows or stops. If left untreated in the legs or feet, for example, this condition can lead to severe pain when walking, gangrene and even amputation.
The DEFINITIVE AR study is designed to evaluate 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. As shown in the DEFINITIVE LE study,
2 directional atherectomy is effective in treating PAD without leaving a permanent implant behind. While the use of drug-coated balloons to treat PAD has demonstrated reduced vessel narrowing, there has been limited clinical study of the effectiveness of this treatment in calcified lesions. Using a directional atherectomy device to remove plaque build-up beforehand may increase how well drug-coated balloons work by improving the uniformity of drug delivery and thereby extending the amount of time the treated vessel stays open and reducing the need for subsequent treatments.
“Covidien is committed to building upon the growing body of clinical evidence for the use of directional atherectomy in the treatment of complex PAD,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We are eager to see the results of DEFINITIVE AR and to understand if this combination therapy of debulking followed by anti-restenotic therapy could lead to improved drug delivery and improved patient outcomes.”