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FDA issues new guidelines for testing of drug-coated stents

Mar 27, 2008 | Associated Press | Chicago Tribune

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.

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

In its most rigorous recommendation, FDA said companies should be prepared to track patients for as long as five years after their stents are approved to monitor blood clots, heart attacks and other potentially fatal events. 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.

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

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 might put patients at higher risk of blood clots, annual sales have plummeted to about $2 billion from a peak of $3.1 billion in 2005.

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