FDA Recommendations on Medical Devices For Treating Blocked Arteries

The U.S. Food and Drug Administration (FDA) announced that it has issued draft guidelines that aid the development, testing and manufacture of Coronary drug-eluting stents, devices used to treat blocked heart arteries.

The draft guidelines, issued by the agency called, the FDA guidance document, outlines the agency's recommendations for pre-market clinical evaluation and post-market studies.

It is based on the efforts of the FDA and the clinical community which has closely monitored these devices, primarily looking into concerns over clot formation in some patients several years after implantation.

"This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients, the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

The draft discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for its complete marketing submission.
It also provides guidance on assessing the toxicity of the drug used to coat the stents, both on its own and as part of the complete product.

Also included in the draft are recommendations guiding engineering tests, biocompatibility tests and animal studies to assess the overall safety of the device.

"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.

In United States, annually, approximately 1 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.

Of these, nearly 65,000 are treated with drug-eluting stents, a scaffolding gadget that is placed into the arteries to help them open.

These 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 arterydefine. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.