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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific PLATINUM program: Company said March 16 it has completed enrollment of the pivotal, randomized, controlled trials of its Promus Element everolimus-eluting stent in small vessels and long lesions. The studies compare Promus Element to historical controls of patients treated with Boston Scientific's Taxus Express2 paclitaxel-eluting stent. The small-vessel trial includes 94 patients with de novo lesions from 2.25 mm to less than 2.50 mm in diameter and up to 28 mm in length; the long-lesion trial enrolled 102 patients with de novo lesions from 24 mm to 34 mm in length and from 2.50 mm to 4.25 mm in diameter. Promus Element received CE-mark approval last fall (1"The Gray Sheet" Nov. 9, 2009). Results of the PLATINUM Workhorse trial comparing Promus Element to Promus, which will be used to support U.S. FDA approval, are expected in early 2011. The firm revealed results of the PERSEUS trial of its platinum-chromium Taxus Element stent at the American College of Cardiology meeting in Atlanta

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