FDA panel backs Abbott's Xience stent

The Circulatory System Devices Advisory Panel to the US Food and Drug Administration has recommended approval for Abbott Laboratories' Xience V Everolimus Eluting Coronary Stent System. This is a next-generation drug-eluting stent intended for use in the treatment of coronary artery disease.

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 antiplatelet therapy. The agency is not required to, but usually follows the recommendations of its advisory committees.

"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the USA have been consistent and significant across the SPIRIT trials," said Gregg Stone, of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, USA, and principal investigator of the SPIRIT III clinical trial. "The robust body of safety and efficacy data support approval of XIENCE V as an important new technology that will enhance the lives of millions of patients with heart disease," he added.