FDA takes closer look at stents

Jeremy Hobson Oct 10, 2007
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FDA takes closer look at stents

Jeremy Hobson Oct 10, 2007
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Lisa Napoli: The Food and Drug Administration will take a closer look at a drug-coated stent from Medtronic today. If the FDA allows the device on the market, it will become one of just three firms in the $2 billion drug-coated stent industry. Jeremy Hobson has more.


Jeremy Hobson: Since safety concerns arose last year, sales have declined for drug-coated stents made by Boston Scientific and Johnson and Johnson. And Medtronic’s device has safety issues of its own. It’s been found to be slightly more likely than its competition to cause blood clots within nine months of being implanted.

Maryann Napoli is with the Center for Medical Consumers:

Maryann Napoli: I’m concerned about the possibility of the FDA allowing another drug-coated stents on the market when we have so many questions about the ones that are already there.

The latest questions stem from Medtronic’s own study of the stent.

But analyst Tim Nelson still expects it will be allowed onto the market.

Tim Nelson: Oh, I think it definitely will be approved by the FDA. There’s nothing in this data set that would indicate that there’s any significant safety or efficacy issues that weren’t previously known with the product.

If approved, analysts expect Medtronic’s stent could capture 15 percent of the U.S. market within a year.

In Washington, I’m Jeremy Hobson for Marketplace.

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