Abbott receives approval for next-generation XIENCE PRIME™ drug eluting stent in Japan

Abbott today announced it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for 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. With this approval in Japan, XIENCE PRIME is available in all of the major markets worldwide, including the United States, Europe, China, India and other countries in the Asia-Pacific and Latin America regions.

“New stent technologies such as XIENCE PRIME play an important role in enhancing the care we provide to patients in Japan who have coronary artery disease,” said Takaaki Isshiki, M.D., Division of Cardiology, Teikyo University Hospital. “XIENCE PRIME retains many of the features that have made XIENCE V an important treatment option for patients, and incorporates improvements that will enhance our ability to access challenging and complex lesions. Importantly, XIENCE PRIME includes a broad size matrix and is the only everolimus eluting coronary stent in Japan with long-length stent sizes of 33 mm and 38 mm.”

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. 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 lengths up to 38 mm to treat long lesions.“XIENCE PRIME leverages the best of XIENCE V, which is the market-leading drug eluting stent in Japan and throughout the world, and the introduction of XIENCE PRIME further advances Abbott’s leadership position,” said Robert B. Hance, senior vice president, vascular, Abbott. “We are pleased to offer this next-generation technology to physicians for the treatment of their patients in Japan, the second-largest healthcare market in the world. XIENCE PRIME is supported by a robust body of clinical evidence, as the XIENCE family of stents has been studied in more than 100 trials in more than 45,000 patients.”

Approval of XIENCE PRIME in Japan was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated XIENCE PRIME in approximately 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 (0.5 percent), with all cases occurring within 30 days and no cases of stent thrombosis reported in patients treated for long lesions.

About the SPIRIT PRIME Clinical Trial

SPIRIT PRIME is a prospective, two-arm, open-label, multi-center pivotal trial designed to evaluate XIENCE PRIME in approximately 500 patients with coronary artery disease. The trial was conducted at more than 60 centers in the United States 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 and U.S. FDA approval in 2011, and is available in the United States, Europe, the Middle East, Japan and several countries in Asia-Pacific and Latin America.

In Japan, 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 ≥2.5 mm to ≤3.75 mm.

In the United States, 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. 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 United States, Europe, Japan and other international markets. In Japan, 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 2.5 mm to 3.75 mm.

In the United States, 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.