FDA Issues Guidance on Drug-eluting Stents

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach yesterday announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

Over the past few years, FDA says it, along with the clinical community, has been closely monitoring these devices with concerns over clot formation in some patients several years after implantation. The draft guidelines, titled "Draft Guidance for Industry on Developing Coronary Drug Eluting Stents," outlines the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns.

Each year in the United States, approximately one million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries, a condition that can cause angina and heart attacks.

Some 650,000 of these patients are treated with drug-eluting stents, a scaffolding device that is placed into the arteries to prop them open. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure opens the artery. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.

"This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

This draft guidance, announced in yesterday's Federal Register (available at www.gpoaccess.gov/fr/index.html) discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers--the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.

"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

A copy of the guidance, can be found at www.fda.gov/cdrh/ode/guidance/6255.html. FDA invites public comment on this draft guidance for 120 days from yesterday's publication in the Federal Register. Typed comments should include the docket number (CD6255), and be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. To submit comments via the Internet, go to www.regulations.gov/search/index.jsp, type in the docket number (CD6255), and follow instructions for comment submission.

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