The circulatory system devices advisory panel to the FDA voted to recommend the Xience V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy.
Abbott filed its premarket approval (PMA) submission for Xience V with the FDA on June 1, 2007. The PMA for Xience V is the first 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.
Xience V was launched in Europe and other international markets in 2006 and is currently an investigational device in the US and Japan.
Gregg Stone, principal investigator of the Spirit III clinical trial, said: “The clinical and angiographic benefits of the Xience V stent compared to the most widely used drug eluting stent available in the US have been consistent and significant across the Spirit trials.”