The Food and Drug Administration (FDA) has approved the next-generation Xience Prime everolimus eluting coronary stent system for the treatment of coronary artery disease.
Xience Prime, which uses the same drug and biocompatible polymer as the Xience V everolimus eluting coronary stent system, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement.
FDA approval of Xience Prime was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label study that evaluated the drug-eluting stent in 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure at one year. Stent thrombosis rates at one year also were very low.
“Drug eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease,” said Marco Costa, principal investigator of the trial, 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, USA. “With Xience Prime, for the first time in the USA, 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.”