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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?
Are DES devices safe?
To this last question the Center for Device and Radiology Health of the FDA seems to be saying: Yes . . . well, at least we think so . . . so we'll have to look again. While supporting the safety of DES technology in a statement issued last week, the agency said it is continuing a close study of new data concerning the devices and that it will convene a meeting of its cardiovascular advisory panel later this year to consider the issue more, and consider the need for labeling changes.
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Source: HighBeam Research, FDA backs block-buster tech, but its evaluation continues.