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FDA “supports” Abott’s new stent


A drug-coated stent made by Abbott Laboratories which is used to restore blood flow to arteries should be approved in the US, government advisers have said.

A panel of medical device experts voted to recommend that the Food and Drug Administration (FDA) approves the Xience stent.

The experts gave their backing to the device on the understanding that the company conducts a follow-up safety study once it reaches the market.

Panellists said the agency and the company should decide the length and size of the study.

The agency does not have to follow the panel’s recommendation, although it usually does.

Johnson & Johnson’s Cypher and Boston Scientific’s Taxus are the only two stents currently on the market in the US, though Medtronic has said that it expects to receive approval for its Endeavor stent in the next month.

Use of drug-coated stents compared with their bare-metal predecessors has declined in the past year on account of evidence the drug coatings may increase dangerous clots.

FDA’s panellists said that Xience’s labelling should instruct patients to use two anti-clotting drugs, including Aspirin and Plavix. The same labelling already appears on the other stents which are currently on the market.

Copyright © PA Business 2007

Abbott Laboratories

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