Abbott Begins Post-Approval Study of Xience V™ Drug-Eluting Stent: Study to Evaluate Treatment of Coronary Artery Disease Patien

Abbott announced the start of the XIENCE V™ USA post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the U.S. Food and Drug Administration approved the Xience V™ Everolimus-Eluting Coronary Stent System. The XIENCE V USA study will evaluate the safety and effectiveness of the Xience V drug-eluting stent in a real-world clinical setting out to five years. Jack Jones, MD, interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kan., was one of the first physicians to enroll a patient into the study. The XIENCE V USA study is designed to evaluate at least 5,000 coronary artery disease patients treated with the Xience V drug-eluting stent at approximately 250 centers across the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by the Dublin/ Academic Research Consortium (ARC). The co-primary endpoint of the study is the composite rate of cardiac death and any heart attack (Q-wave or non-Q-wave myocardial infarction) in patients at one year. Secondary endpoints of the study include patient compliance with prescribed anti-platelet medication, measures of re-treatment by stenting or surgery, and device and procedural success. Xience V was approved by the U.S. Food and Drug Administration on July 2, 2008, and was launched in Europe and other international markets in October 2006. Abbott also supplies a private-label version of Xience V to Boston Scientific called the Promus™ Everolimus-Eluting Coronary Stent System. Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies. Additional information about Xience V is available online at www.xiencev.com.

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