In July 2008, XIENCE V was launched in the United States. The addition of a 2.25 mm size would complement the broad range of XIENCE V lengths and diameters. Upon U.S. Food and Drug Administration (FDA) approval of the 2.25 mm stent system, the device will be called XIENCE NANO(TM) in the United States. The XIENCE V 2.25 mm stent system received CE Mark (Conformite Europeene) approval and was launched in various countries in Europe, Asia and Latin America in March 2008.
"Treatment of lesions in small coronary vessels is often complex and associated with higher rates of complications. Being able to deliver a stent accurately to the diseased area of the vessel is crucial for successful treatment," said Marco Costa, M.D., Ph.D., director of Invasive Services, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals, Case Western Reserve University, and principal investigator of the SPIRIT Small Vessel trial. "Given the strong clinical performance and ease of use of XIENCE V, a smaller stent system would significantly enhance the treatment options for patients with coronary artery disease in small vessels."
The SPIRIT Small Vessel trial is designed to study 250 patients at approximately 50 centres in the United States. The primary endpoint is a composite measure of cardiac death, heart attack (target vessel myocardial infarction) and target lesion revascularisation (repeat procedures on the treated vessel) at one year.