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Article: FDA backs block-buster tech, but its evaluation continues.
- Article from:
- Medical Device Daily
- Article date:
- September 18, 2006
CopyrightCOPYRIGHT 2006 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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?
Are DES ...