Abbott Announces FDA Approval and U.S. Launch of Next-Generation XIENCE Xpedition™ Drug-Eluting Stent System
Abbott Park, Illinois (January 3, 2013) — Abbott today announced that the Xience Xpedition Everolimus Eluting Coronary Stent System received U.S. Food and Drug Administration (FDA) approval and is launching immediately in the United States with the largest size matrix in the U.S. market. Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies.
Samin K. Sharma, MD, director of Clinical and Interventional Cardiology, dean of International Clinical Affiliations, and president of the Mount Sinai Heart Network at Mount Sinai Medical Center, New York, was the first physician to implant a patient with Xience Xpedition in the United States.
Abbott's Xience drug-eluting stents, including the newly approved Xience Xpedition, are the first and only drug-eluting stents in the U.S. market to be proven safe for direct stenting.
Xience Xpedition will be available in the largest size matrix in the U.S. market, with both rapid exchange (RX) and over-the-wire (OTW) configurations, providing physicians with the most popular delivery platforms. Xience Xpedition has diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm, for more accurate vessel sizing.