FDA panel recommends approval of Abbott stents

Abbott Laboratories' Xience. Source: Abbott Laboratories

Dec. 6 – The Circulatory System Devices Advisory Panel to the FDA recommended approval for Abbott Laboratories’ Xience V and Promus everolimus-eluting coronary stent systems. Both stent systems would be covered by the same FDA approval.

The Promus and Xience V stent systems are identical products manufactured by Abbott, but the Natick, Mass.-based Boston Scientific distributes Promus on the international market. Xience V was launched in Europe and other international markets in 2006.

The FDA advisory committee voted to recommend the Xience V stent system for approval with conditions related to post-marketing study requirements and language related to dual anti-platelet therapy, according to the Abbott Park, Ill.-based company. The FDA usually follows the recommendations of its advisory panels, but is not required to.

Abbott filed for premarket approval (PMA) submission for Xience V with the FDA on June 1. 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, Abbott said.

Promus and Xience V are currently investigational devices in the United States and Japan, and therefore have not been approved for sale.