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Boston Scientific Begins Clinical Trial Enrollment in China for PROMUS Element™ Everolimus-Eluting Stent
Date:1/26/2011

ty while permitting thinner struts compared to prior-generation stents(1).

"PLATINUM China represents the Company's first major coronary drug-eluting stent trial with enrollment exclusive to China," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer, Cardiology, Rhythm and Vascular Group for Boston Scientific.  "The Element Stent series has been well received by physicians in CE Mark countries, and we look forward to bringing this advanced coronary stenting technology to Chinese physicians and their patients."

The Company received CE Mark approval for the PROMUS Element Everolimus-Eluting Stent System in October 2009 and for the TAXUS® Element™ Paclitaxel-Eluting Stent System in May 2010.  Both Element systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.

"We are excited to begin evaluating the PROMUS Element Stent in China," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific.  "The advanced platinum chromium alloy and new balloon catheter offered in the Element Stent System represent significant improvements over prior-generation stents.  We are confident that the next-generation Element platform will further extend our global drug-eluting stent leadership."

In the U.S., the Company expects Food and Drug Administration approval for the TAXUS Element Stent System(2) in mid 2011 and for the PROMUS Element Stent System in mid 2012.  In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.

In the U.S., the PROMUS Element Stent System and the TAXUS Element Stent System are investigational devices and are limited by applicable law to investigational use only and are not available for sale.  

(1) Based on bench testing.  Data on file
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