US FDA proposes guidelines for stent manufacturers

By Susan Heavey

WASHINGTON, March 26 (Reuters) - The U.S. Food and Drug Administration proposed guidelines on Wednesday for stent manufacturers on how to develop, make and test drug-coated heart stents after some patients with stents got blood clots.

While the proposal is not binding, companies often seek the FDA's advice during product development.

The FDA's draft proposal also asks for more information about a product's risks before clinical trials and for additional studies to be conducted after a product's approval.

"The draft guidelines issued today ... outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns," the FDA said.

Stents are small wire mesh tubes designed to keep arteries open after doctors have cleared them from blockages. Some stents include a scar-reducing drug coating.

The once $6 billion industry has had sales declines because of safety concerns.

Currently approved products include Medtronic Inc.'s (MDT.N: Quote, Profile, Research) Endeavor, Boston Scientific Corp.'s (BSX.N: Quote, Profile, Research) Taxus, and Johnson & Johnson's Cypher (JNJ.N: Quote, Profile, Research). Abbott Laboratories (ABT.N: Quote, Profile, Research) is also working on a stent called Xience.

Abbott spokeswoman Kelly Morrison said the company does not expect the FDA's proposal to affect Xience, in its final stages of review by the agency.