updated 3/26/2008 3:23:29 PM ET 2008-03-26T19:23:29

The Food and Drug Administration on Wednesday laid out new guidelines for the testing of drug-coated stents, two years after safety concerns first reduced their use.

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The proposed guidelines posted to FDA's Web site recommend device makers conduct large, analytic studies of their stents both before and after they are submitted to FDA.

In its most rigorous recommendation, FDA said companies should be prepared to track patients for up to five years after their stents are approved to monitor blood clots, heart attack and other potentially fatal events. Such long-term studies can cost companies millions of dollars.

Stents are tiny, mesh-wire tubes that prop open arteries after they have been surgically cleared of fatty plaque. They quickly became a highly lucrative business, after companies began adding drug coatings to the devices in 2003 to prevent scar tissue from growing over the mesh-wire.

But after data suggested that the drug coatings may put patients at higher risk of blood clots, sales have plummeted to about $2 billion from a peak of $3.1 billion in 2005.

A series of studies in 2006 showed that months after they are implanted, stent coatings can increase the risk of life-threatening blood clots unless patients continue to take anti-clotting drugs. Medical societies urge patients to continue taking the drugs for at least a year after implantation.

However, recent studies have suggested the risks of drug-coated stents are no greater than those of regular, bare-metal stents.

FDA's proposal is aimed at gathering enough data from companies to confidently determine if stents increase the likelihood of clots and other heart-related problems already a risk for patients who get the devices. The agency's medical-device advisers have complained repeatedly about the lack of such information.

"Under this proposal, larger and longer post-approval studies will be required, meaning we'll have better information sooner to help manage patients," said Dr. William Maisel, a cardiologist at Boston's Beth Israel Deaconess Medical Center who previously chaired the FDA advisory panel on the devices.

Maisel said, however, that FDA's proposal is unclear about whether second-generation stents will be subject to the tougher safety requirements.

FDA's director for medical devices, Daniel Schultz, said the guidance should give companies recommendations for how to "minimize the risks while preserving for patients the benefits of drug-eluting stents."

About 650,000 people in the U.S. receive stents each year, according to the FDA.

FDA guidelines are not legally binding, but companies typically follow them to ensure approval of their devices. The agency will take comments on the proposed guidelines for 120 days before redrafting them and issuing final guidelines.

There are three drug-coated stents available in the U.S.: Boston Scientific Corp.'s Taxus, Medtronic Inc.'s Endeavor and Johnson & Johnson's Cypher.

FDA is reviewing another drug-coated stent from Abbott Laboratories as well as Boston Scientific's second-generation Taxus-Liberte stent. A spokeswoman for Abbott said it does not expect the guidelines to affect approval of its Xience stent, which is expected in the second quarter.

Boston Scientific is barred from launching new devices under an FDA warning and recently received a letter from the agency saying it wants additional time to review its Taxus-Liberte stent.

A company spokesman said Wednesday the company expects the hold on new products to be lifted by mid-2008.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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