Abbott receives FDA approval for new stent

Libertyville Township-based Abbott Laboratories said it has received U.S. Food and Drug Administration approval for the next-generation XIENCE PRIMET Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

With the introduction of XIENCE PRIME in the United States, Abbott now offers physicians an expanded range of drug eluting stents supported by the clinical results from the SPIRIT family of trials. XIENCE PRIME features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement.

“Drug eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease,” said Marco Costa, M.D., Ph.D., professor of medicine, director of the Interventional Cardiovascular Center and director of the Research and Innovation Center, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals, Case Western Reserve University in Cleveland, Ohio, and principal investigator of the global SPIRIT PRIME trial.

“With XIENCE PRIME, for the first time in the U.S., physicians have a 38 mm everolimus-eluting stent for the treatment of long lesions. The enhanced deliverability and wide range of sizes, including a small-vessel 2.25 mm-diameter stent, will improve our ability to access challenging, complex lesions, and thereby improve care for our patients.”