Anti-Restenosis Stent Coated with Paclitaxel

The U.S. Food and Drug Administration (FDA) has given Cook approval to proceed with U.S. evaluation. The stent's metal body is coated with a minute quantity of paclitaxel, which is gradually released into the cells of the arterial wall. There, paclitaxel acts to prevent excessive cell regrowth at the site of the angioplasty, which researchers hope will reduce or eliminate restenosis. The Logic stent is indicated for use in patients with symptomatic ischemic heart disease or with a positive cardiac stress test, due to new lesions in native coronary arteries with a reference vessel diameter in the range or 3.0-4.0 mm.

"Cook was the first interventional cardiology company to begin multicenter trials of a paclitaxel-coated stent overseas, and the FDA's decision means we will be first to begin evaluating this highly promising technology in the United States,” said Phyllis McCullough, president and CEO of Cook.



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