Abbott said the US Food and Drug Administration (FDA) Circulatory System Devices Advisory Panel has recommended approval for the Xience V, an experimental drug-coated stent for heart patients.
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 FDA usually follows the recommendations of its advisory committees.
Xience V Everolimus Eluting Coronary Stent System is a next-generation drug eluting stent intended for use in the treatment of coronary artery disease.
"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," said Gregg W. Stone, M.D, Columbia University Medical Center and the Cardiovascular Research Foundation, New York 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."
Abbott filed its Pre-Market 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 randomised controlled head-to-head trial with a market leading product.
"The outcome of today's advisory committee meeting is very encouraging," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the US."
Xience V was launched in Europe and other international markets in 2006 and is currently an investigational device in the United States and Japan.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.