Drug-Coated Stents Merit New Studies, FDA Says: Agency’s Guidelines Address Blood Clot, Other Safety Issues

By Christopher Snowbeck, Pioneer Press, St. Paul, Minn.

Mar. 27–Drug-coated stents merit new studies, FDA says — More than a year after the multibillion-dollar market for drug-coated stents was first roiled by concerns about blood clots forming in the devices, the U.S. Food and Drug Administration issued recommendations Wednesday for better studies from manufacturers that might address both the blood clot issue and other safety questions.

Among other things, the recommendations provide guidance for assessing the toxicity of the drugs used to coat stents — metal mesh tubes that doctors use to prop open heart arteries obstructed with blockages.

Natick, Mass.-based Boston Scientific is the market leader in drug-coated stents and manufactures the products at a division based in Maple Grove. The company’s worldwide sales of drug-coated stents — which dropped from $2.4 billion in 2006 to $1.8 billion last year — have been hurt both by the blood clot concerns and questions raised in medical studies about whether the devices have been overused.

The U.S. market for drug-coated stents is expected to undergo a shake-up this year because of the introduction of a product from Fridley-based Medtronic, as well as a forthcoming stent from Illinois-based Abbott Laboratories. Before this year, only Boston Scientific and New Jersey-based Johnson & Johnson had approval to sell drug-coated stents in the U.S.

Lawrence Keusch, an analyst with Goldman Sachs, told investors in a note Wednesday that the FDA recommendations should benefit patients and likely will become final

following a 120-day comment period. For companies, Keusch wrote, it’s a mixed bag.

It will cost companies more money, he noted, though “for those companies that currently are on the U.S. market (or are about to gain FDA clearance, as is the case with Abbott), the revised guidelines are likely to keep new competitors out of the market until 2012.”

Dr. Bill Maisel, a device safety expert at Beth Israel Deaconess Medical Center in Boston, said the FDA document calls on companies to perform larger and longer follow-up studies on the safety of products once they reach the market. Such recommendations are “both encouraging and expected.” Maisel said.

Each year in the U.S., some 650,000 patients are treated with drug-coated stents, the FDA says.

The coating on these stents slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure to open an artery. Any such buildup of this scar tissue could mean patients must undergo repeat procedures.

Boston Scientific and Medtronic officials said they were reviewing the draft guidance and would submit comments in the future.

Christopher Snowbeck can be reached at 651-228-5479.

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