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FDA backs block-buster tech, but its evaluation continues.
DES: new questions about safety, endpoints
FDA backs block-buster tech, but its evaluation continues
By DON LONG
Medical Device Daily Managing Editor
Was the FDA too hasty in approving what has become a blockbuster medical product? Do drug-eluting stents (DES) provide any benefits beyond the avoidance of redundant procedures to open clogged arteries? Have all of the questions been answered concerning the appropriate uses of these devices in the appropriate patients? And the appropriate doses? And what are the proper dosages of follow-on drugs? Do DES devices provide added benefit in terms of increased mortality?
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