FDA backs block-buster tech, but its evaluation continues.

Publication: Medical Device Week

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COPYRIGHT 2006 Thomson Healthcare, Inc.

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...

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