The Food and Drug Administration awarded approval to
Xience V, a move that allows the drug-eluting stent to compete in the U.S. open market with
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
, 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
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.