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Published on 27 March 2008

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FDA wants more stent safety data

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The Food and Drug Administration (FDA) has set out new guidelines for the testing of drug-coated stents.

The FDA’s proposed guidelines recommend stent manufacturers conduct large, analytic studies of their products both before and after they are submitted to the agency.

And it said that companies should be prepared to track patients for up to five years after their stents are approved to monitor blood clots, heart attack and other potentially fatal events.

The devices are used to prop open arteries after they have been surgically cleared of fatty plaque.

They became highly profitable after manufacturers began adding drug coatings to them in 2003 to prevent scar tissue from growing over the mesh-wire.

But after reports suggested that the drug coatings may put patients at higher risk of blood clots, sales have plummeted to about $2bn from a peak of $3.1bn in 2005.

FDA guidelines are not legally binding, but companies typically follow them to ensure their devices are approved.

The FDA said it will consult on the proposed guidelines for four months before redrafting them and issuing final guidelines.

Copyright © PA Business 2008

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