From: Reuters
Published December 14, 2007 04:58 AM

FDA seen toughening coated-stent requirements: WSJ

NEW YORK (Reuters) - The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.

In an article on Friday, the Journal reported that the FDA's revised requirements are in response to safety concerns about the drug-coated stents.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep the vessels from reclogging.

Drug-coated stents, made by companies including Boston Scientific Corp, Johnson & Johnson and Medtronic Inc, were once near $6 billion a year market, but that has contracted sharply amid concerns the stents could cause complications. Some patients developed blood clots months after having the devices implanted, and many doctors reverted to older and cheaper bare-metal stents.

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The FDA's new guidelines, will likely be stricter around the recommended time patients should take an anticlotting drug after receiving a new stent, and the numbers of patients and length of time used to test new stents, the Journal reported. Under the new guidelines, the testing period could go on before and after the FDA approves the project, according to the newspaper.

The more stringent guidelines are not likely to affect stents that are already on the market, the Journal said.

(Reporting by Emily Chasan)

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