Drug-coated heart stents will undergo review by a U.S. advisory panel by the end of the year after reports of blood-clotting associated with the devices.
The Food and Drug Administration said it intends to "more formally evaluate" studies that were presented at medical meetings in Atlanta and Barcelona, where Chicago-based Abbott Laboratories was among companies presenting data on the devices.
"Drug-eluting stents offer substantial clinical benefits to patients," Abbott spokesman Jonathan Hamilton said, a view echoed by the FDA.
The devices "remain safe and effective when used for the FDA approved indications," the FDA said in a Web posting announcing the review. "These devices have significantly reduced the need for a second surgery to treat" renarrowing of blood vessels for thousands of patients each year.
Boston Scientific last week said it found a small risk of blood clots developing inside its drug-coated heart stents months after doctors placed them in diseased blood vessels to keep them open. Johnson & Johnson says it hasn't found similar problems.
Monday, December 4, 2006
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