US Pharm. 2008;33(5):69.

The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries. Each year in the U.S., approximately one million patients undergo procedures to treat coronary atherosclerosis, and some 650,000 of them are treated with drug-eluting stents. Concerned about clot formation in some patients years after implantation, the agency has monitored the devices closely over the past several years.

Three coronary drug-eluting stents are currently FDA-approved. The guidance document also assesses the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. These stents combine device and drug technology and, as such, the document contains expertise and input from two agency centers--the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

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


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