Abbott Receives U.S. FDA Approval for XIENCE nano™ to Treat Coronary Artery Disease in Small Vessels
ABBOTT PARK, Ill., May 24, 2011 /PRNewswire/ -- Abbott (NYSE: ABT) today 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.
"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.
"As a global leader in vascular care, we are pleased to build upon our XIENCE franchise with the launch of XIENCE nano in the United States – expanding the treatment options for the approximately 10 percent of procedures that utilize a 2.25 millimeter stent," said Robert Hance, senior vice president, vascular, Abbott. "XIENCE nano leverages the positive safety and efficacy clinical results consistently demonstrated with XIENCE V, which has become the leading drug eluting stent platform worldwide. The introduction of XIENCE nano reinforces our commitment to extending the innovations we bring to physicians for their patients."
The XIENCE family of drug eluting stents is now available in the United States in a comprehensive range of diameters from 2.25 mm to 4.0 mm. XIENCE nano features thin struts measuring 0.0032".
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the U.S., Europe, Japan and other international markets.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available at http://www.abbottvascular.com/us/xience-v.html or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott information is available on the company's Web site at www.abbott.com.