FDA OKs Abbott's Xience V Stent - TheStreet

FDA OKs Abbott's Xience V Stent

The drug-eluting stent will hit the U.S. market immediately.
Publish date:

The Food and Drug Administration awarded approval to

Abbott Labs

(ABT) - Get Report

Xience V, a move that allows the drug-eluting stent to compete in the U.S. open market with

Boston Scientific's

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Taxus for the treatment of patients with coronary artery disease.

Abbott, which announced the approval after Wednesday's market close, said it will launch Xience V in the U.S. immediately. Xience V was launched in Europe in October 2006, and it's under review for regulatory approval in Japan.

Xience V is implanted to prop open a narrowed or blocked coronary artery. It releases everolimus, an mTOR inhibitor drug developed by


(NVS) - Get Report

, in a controlled fashion to help prevent the artery from becoming blocked again.

The Xience V and Taxus stents were compared in two clinical trials. In May, Abbott released two-year data from the Spirit III trial that showed Xience V stent delivered a 45% reduction in the risk of major cardiac events and a 32% reduction in the risk of cardiac events related to the treated vessel at two years in comparison to the Taxus device.

Xience V will also compete with other drug-coated stents, namely

Johnson & Johnson's

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Cypher and


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Abbott shares were up 85 cents, or 1.6%, at $55.09 in recent after-hours trading Wednesday. Boston Sci dipped a penny at $12.40; and shares of J&J and Medtronic were unchanged.

This article was written by a staff member of TheStreet.com.