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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Firm's System One daily home hemodialysis system is for dialysis treatment, and the latest results of the ongoing FREEDOM study showed that fewer patients treated with the device experienced restless legs syndrome symptoms versus baseline and that overall sleep quality improved after four months. "The Gray Sheet" (1March 22, 2010) originally misstated the intended use of the device