Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Abbott DES Trial: Abbott announces start of SPIRIT PRIME, the U.S. clinical trial of its next-generation Xience Prime everolimus-eluting coronary stent, during its July 15 second-quarter earnings call. The company expects to launch Xience Prime in the U.S. in 2012. Abbott recently began shipping Xience Prime to select accounts in Europe following receipt of a CE Mark in June (1"The Gray Sheet" June 29, 2009). Xience Prime is available in a broad range of sizes up to 38 mm. SPIRIT PRIME is a 500-patient, 75-center nonrandomized trial with two arms. The core size arm will follow 400 patients treated with a stent from 2.25 mm to 4.0 mm in diameter and 8 mm to 28 mm in length, and the long lesion arm will follow 100 patients with a stent 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint is major adverse cardiac events
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Xience Prime time
Abbott receives CE mark approval for the next-generation everolimus-eluting coronary stent, clearing the way for a European market launch in the third quarter, the firm says June 23. Xience Prime uses the same drug and biocompatible polymer as Abbott's market-leading Xience V stent, available in the U.S. and Europe, but has a novel design and modified delivery system for greater flexibility and improved deliverability, the company says (1"The Gray Sheet" July 7, 2008). Xience Prime will be available in a broad range of sizes, including Prime SV for small vessels and Prime LL for long lesions