Abbott Receives U.S. FDA Approval for XIENCE nano to Treat Coronary Artery Disease in Small Vessels
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for the XIENCE nano™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in small vessels. XIENCE nano, which is based on the same platform as the XIENCE V® Everolimus Eluting Coronary Stent System, 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.
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.
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