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FDA panel of experts recommends approval for Medtronic's drug-coated Endeavor stent


Medtronic's drug-coated stent Endeavor cleared a major regulatory hurdle Wednesday, as government advisers recommended approval for the medical device.

A panel of outside experts unanimously recommended the Food and Drug Administration approve the device with certain follow-up requirements for Medtronic, according to agency spokeswoman Karen Riley. Panelists were still discussing the details of those conditions late Wednesday.

While FDA is not required to follow the panel's advice, most analysts expect the agency to give Medtronic approval later this year to compete in the roughly $2 billion U.S. market for drug-delivering stents. Currently Boston Scientific Inc. and Johnson and Johnson are the only companies who currently market the products.

Copyright 2007 AP Features
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Author:MATTHEW PERRONE
Publication:AP Features
Date:Oct 10, 2007
Words:108
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