FDA to review drug-coated stents

Helen Palmer Dec 7, 2006
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FDA to review drug-coated stents

Helen Palmer Dec 7, 2006
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MARK AUSTIN THOMAS: Today the FDA will review the safety of drug-coated stents. Some studies suggest they could be harmful. From the Health Desk at WGBH, Helen Palmer reports.


HELEN PALMER: Drug coated stents are four times as costly as older bare metal ones. But cardiologists love them, because they keep scar tissue from closing arteries up again.

Now studies show a small risk of deadly blood clots forming and that’s hurt market share, says analyst Candice Mahboubi of Millenium Research.

CANDICE MAHBOUBI: Instead of 90% it’s actually more like 84%. So translating to about $200 million in loss in the drug eluting stent market.

Lehman Brothers analyst Bob Hopkins thinks doctors on the FDA panel will likely suggest longer follow-up studies on these stents, and perhaps tougher rules for new products.

He thinks prices and usage will fall somewhat, but the stents will still be very profitable. Just don’t expect the market to grow at the 10% pace stent makers are forecasting.

In Boston, I’m Helen Palmer for Marketplace.

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