Abbott receives U.S. FDA approval for next-generation XIENCE PRIME™ Drug Eluting Stent
Posted: 1 November 2011 | | No comments yet
FDA approval for the next-generation XIENCE PRIME™ Drug Eluting System…
Abbott today announced it has received U.S. Food and Drug Administration (FDA) approval for the next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. With the introduction of XIENCE PRIME in the United States, Abbott, the worldwide leader in drug eluting stent technology, now offers physicians an expanded range of drug eluting stents supported by the clinical results from the SPIRIT family of trials. 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.
“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.”
XIENCE PRIME is based on the stent design of the MULTI-LINK family. It utilizes cobalt chromium technology and features a “peak-to-valley” mechanical design that imparts longitudinal strength and stability to the stent. To date, the stents based on the MULTI-LINK design – including VISION® , XIENCE V, PROMUS® and XIENCE PRIME – represent more than 300 million implant months, which is a measure of the clinical experience that supports this stent design. In addition, XIENCE PRIME features one of the thinnest drug eluting stent struts available while maintaining radial strength to support the vessel, and it provides excellent visibility under X-ray during stent implantation procedures. XIENCE PRIME is offered in long lengths up to 38 mm.
“Abbott is the worldwide leader in drug eluting stent technology, and U.S. approval of XIENCE PRIME will further advance our number-one position in the global drug eluting stent market,” said Robert B. Hance, senior vice president, vascular, Abbott. “XIENCE PRIME and XIENCE V are the only drug eluting stents that are directly supported by the robust body of clinical evidence from the SPIRIT family of trials. Together, these two stent platforms expand the range of treatment options that we offer physicians for the benefit of their patients with coronary artery disease.”
FDA approval of XIENCE PRIME was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated XIENCE PRIME in 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure (TLF) at one year. Stent thrombosis rates at one year also were very low. The full results from the SPIRIT PRIME study will be presented by Dr. Costa on Tuesday, Nov. 8, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
About the SPIRIT PRIME Clinical Trial
SPIRIT PRIME is a prospective, two-arm, open-label, multi-center registry designed to evaluate XIENCE PRIME in 500 patients with coronary artery disease. The trial was conducted at more than 60 centers in the U.S. and Australia. Two registry arms were evaluated: the Core Size arm and the Long Lesion arm. The Core Size arm utilized XIENCE PRIME stents measuring 2.25 mm to 4.0 mm in diameter and from 8 mm to 28 mm in length. The Long Lesion arm utilized XIENCE PRIME stents measuring 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint was TLF at one year, which was a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
About XIENCE PRIME and XIENCE V
XIENCE PRIME received CE Mark in 2009. With FDA approval, XIENCE PRIME is now available in the U.S., Europe, the Middle East and most of Asia.
XIENCE PRIME is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.25 mm to ≤4.25 mm. Additional information about XIENCE PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_PRIME_Everolimus_Eluting_Coronary_Stent_System.pdf.
Abbott’s market-leading XIENCE V drug eluting stent is marketed in the U.S., Europe, Japan and other international markets.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤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 www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.
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 vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.