Advisory Committee Recommends Approval of Abbott’s Drug-Eluting Stent System
The Circulatory System Devices Advisory Panel to the FDA has recommended approval for Abbott’s Xience V Everolimus Eluting Coronary Stent System, a next-generation drug-eluting stent intended for use in the treatment of coronary artery disease.
The FDA advisory committee voted to recommend the stent system for approval with conditions related to postmarketing study requirements and language related to dual antiplatelet therapy, the company said. The FDA is not required to follow the recommendations of its advisory committees but usually does.
Abbott filed its premarket approval (PMA) submission for Xience V June 1. It was the first PMA to include data demonstrating superiority of one drug-eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market-leading product.
The stent system was launched in Europe and other international markets in 2006 and is an investigational device in the U.S. and Japan.