Drug-Coated Stent Inches Toward Approval

FDA Advisers Recommend Heart Device

WASHINGTON -- A device to help heart patients is moving a step closer to the market.

Advisers to the Food and Drug Administration recommended a new drug-coated heart stent, if the company that makes them meets a list of conditions.

The Cordis CYPHER Sirolimus-eluting Stent from Johnson & Johnson props open clogged arteries, and keeps them open by emitting a drug normally used to prevent organ rejection in kidney transplants.

The stent gained approval in Europe last spring and is now available in more than 50 countries.

The FDA advisers say the stent should be approved for sale if Johnson & Johnson mandates that it clears only certain-sized blockages and provides clearer information for doctors and patients about the stent's effects.

The advisers also say the company should promise to keep track of the people who initially test the stent to see how it holds up in the long term.

The panel calls the new stent "an important advance."

The FDA isn't bound by its advisers' recommendations, but usually follows them.

Additional Resources:

• Johnson & Johnson
• Food and Drug Administration

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