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Boston Scientific Completes Enrollment in Pivotal Workhorse Trial for Next-Generation Everolimus Stent
Date:9/18/2009

NATICK, Mass., Sept. 18 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the completion of patient enrollment in the workhorse portion of its PLATINUM clinical program. PLATINUM is a global, randomized, pivotal controlled trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the platinum chromium PROMUS((R)) Element(TM) Everolimus-Eluting Coronary Stent System. The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites worldwide, and completed enrollment two months ahead of schedule.

The PLATINUM workhorse trial evaluates the new PROMUS Element Everolimus-Eluting Coronary Stent in comparison with the current PROMUS Stent, which uses the same drug dose and polymer on an earlier cobalt chromium alloy stent design. Two parallel sub-trials will evaluate the PROMUS Element Stent in small vessels and long lesions. In addition to the PROMUS Element Everolimus-Eluting Stent, the Company is developing additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial compares the TAXUS((R)) Element(TM) Stent to the TAXUS Express2(TM) Stent. The PERSEUS trial completed enrollment in October 2008, and the primary endpoint will be reported at the ACC conference in 2010.

"The brisk enrollment in the PLATINUM trial reflects the strong interest in this new platinum chromium stent platform," said Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital and Principal Investigator of the trial.

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