FDA to vote on approval for Abbotts Xience stent that outperformed Boston Scientifics Taxus

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Abbott Laboratories' Xience. Source: Abbott Laboratories  

Abbott Laboratories on Tuesday released its trial results showing its drug-eluting stent (DES), Xience, is safer and more effective Boston Scientific’s DES Taxus. Based on the results, an FDA panel is scheduled to vote on Thursday whether Xience should be approved in the United States.

The Chicago-based Abbott will present its clinical data to the Circulatory System Devices Advisory Panel, which will review the data and recommend if the FDA should approve Xience for the treatment of coronary artery disease. The FDA panel is expected to ask its panel if Abbott has collected enough data to ensure Xience's long-term safety.

Briefing documents released by the FDA confirm that the Xience is superior to the Taxus on all major efficacy and safety measurements, Abbott said.

In preliminary two-year study compiled by Abbott comparing Xience with Taxus, patients with the Abbott device had 50 percent fewer major heart problems. However, in Tuesday's review of the data, FDA advisers cautioned against making firm conclusions based on Abbott's analysis. Abbott also presented the design of Xience V Everolimus Eluting Coronary Stent System (EECSS) U.S. post-approval study, which will include approximately 5,000 Xience V patients, who will be consecutively enrolled at up to 275 sites in the United States.

Last month, Medtronic presented to the same panel on its two-year data on 1,300 patients. The panel unanimously recommended approval for its Endeavor stent, which is expected to get FDA clearance by 2008.

Boston Scientific Taxus and Johnson & Johnson's Cypher are currently the only drug-coated stents on the U.S. market.