March 17, 2008 / 8:29 PM / in 11 years

FDA official says heart stent guidelines near

SILVER SPRING, Maryland (Reuters) - New guidelines for the testing of drug-coated heart stents will be released soon, the Food and Drug Administration’s device chief said on Monday.

The guidelines are meant to address concerns that drug-coated heart stents are more likely than bare-metal versions to raise the risk of blood clots months after the devices are implanted.

Dr. Daniel Schultz told reporters the publication of proposed guidelines was “imminent.” Asked to be more specific, he said they would be unveiled within days or weeks.

“Our goal is that we have a high bar, but that we have people understand exactly what we want to see so there aren’t too many detours in getting things to market,” said Schultz, director of the FDA’s Center for Devices and Radiological Health.

He added the long-awaited document will address stent design, the polymer used to adhere a drug to stents and the drugs used, among other factors for laboratory and human testing.

Stents are tiny wire-mesh tubes that doctors implant to prop open arteries that have been cleared of blockages. Drug coating was added to newer versions to reduce the chances of artery reclogging.

Johnson & Johnson, Boston Scientific Corp and Medtronic Inc make the drug-coated stents now on the market. Abbott Laboratories Inc also is expected to receive approval for a new drug-coated stent.

Once a $6 billion a year market, drug-coated stents were hailed as a major medical advance in 2003, when J&J’s device was approved and the newer generation rapidly replaced cheaper and older bare-metal stents in many uses.

But the emergence of an increased risk of blood clots in some patients months later led some doctors to switch back to bare-metal stents.

Still another large study, released late last year, suggested patients who received drug-coated stents were not more likely to die or suffer heart attacks than those who got bare-metal versions, fanning the debate further.

The FDA’s Schultz said the agency has tried to learn from that initial experience and is working with companies as they embark on newer versions.

“We would like to see broader premarket trials ... but probably more importantly we need to have post-market studies that are what we call large simple trials that really do look at a broad experience of all these different types of patients,” he said.

The Wall Street Journal reported in December that Schultz said the stent guidelines would be released within a few weeks.

Reporting by Susan Heavey and Lisa Richwine; Editing by Andre Grenon

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