New draft guidelines may change the way coronary stents wend their way to market.

On March 26, the U.S. Food and Drug Administration announced new 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 and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation,’ said the agency in a press release.

The draft guidelines -- an FDA ‘guidance document’ -- outline the agency’s recommendations for pre-market clinical evaluation and post-market studies, two steps designed to address safety concerns including the clotting concern.

About one million patients with coronary atherosclerosis are treated each year, with about 65 percent of them receiving drug-eluting stents, scaffolding devices that is placed into the arteries to prop them open. To date, the FDA has approved three coronary drug-eluting stents.

‘This draft guidance is part of the FDA’s ongoing effort to provide the industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents,’ said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health, in a prepared statement.

To review a copy of the guidance, ‘Draft Guidance for Industry on Developing Coronary Drug Eluting Stents,’ go to www.fda.gov/cdrh/ode/guidance/6255.html. The FDA will accept public comment on the guidance for 120 days from its March 26 publication in the Federal Register.

The FDA is planning a public workshop on drug-eluting stents for the purpose of soliciting comments on the guidance. For information on the date and location of the workshop, which the agency had not announced at press time, go to www.fda.gov.