FDA Approves Xience Nano Stent to Treat Small Coronary Vessels


May 25, 2011

May 25, 2011 – The U.S. Food and Drug Administration (FDA) cleared the Xience nano everolimus-eluting coronary stent system for the treatment of coronary artery disease in small vessels. The Xience nano, which is based on the same platform as the Xience V everolimus-eluting coronary stent, offers physicians in the United States a new option for treating patients with coronary artery disease in vessels as small as 2.25 mm in diameter.

"The treatment of small vessels is often complex and associated with higher rates of complications compared to larger vessels," said Marco Costa, M.D., Ph.D., professor of medicine, director of the Interventional Cardiovascular Center, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio, and principal investigator of the SPIRIT Small Vessel clinical trial. "I am confident that the highly deliverable Xience nano stent, with its thin struts and effective everolimus-eluting platform, will help physicians treat their patients who have coronary artery disease in small vessels."

FDA approval of Xience nano was supported by results from the SPIRIT Small Vessel clinical trial, which showed very low late loss (a measure of vessel re-narrowing) of 0.20 mm and a target lesion failure (TLF) rate of 8.1 percent, which is comparable to results observed in the SPIRIT clinical trials with Xience V. TLF is defined as a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR).

Small vessels often are associated with increased levels of restenosis, or tissue re-growth, following a stent implantation. With its cobalt chromium stent design, high deliverability and everolimus drug coating used to prevent abnormal tissue growth, Xience nano is designed to be an optimized treatment for coronary artery disease in patients who have small vessels.

Boston Scientific also announced its launch of the 2.25 mm Promus stent, which is a private-labeled Xience nano everolimus-eluting coronary stent. It is manufactured by Abbott and distributed by Boston Scientific under a 2006 agreement, when Abbott purchased the Xience stent technology from Boston.

For more information: www.abbottvascular.com/us/xience-v.html