FDA Advisory Committee Recommends Approval of XIENCE
December 6, 2007 — The Circulatory System Devices Advisory Panel to the FDA has recommended approval for the 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 XIENCE V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy.
“The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials,” said Gregg W. Stone, M.D., of 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 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 insegment late loss in a randomized 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 U.S.”
XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the U.S. and Japan.
For more information: www.abbott.com
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