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Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent
Date:2/3/2009

a choice of two different drugs on its drug-eluting stent (DES) platform."

The global Principal Investigator for the trial is Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York. The U.S. Co-Principal Investigator is Paul Teirstein, M.D., of Scripps Green Hospital in La Jolla, California, and the International Co-Principal Investigator is Ian Meredith, M.D., Ph.D., Director of Cardiology at the Monash Medical Centre in Melbourne, Australia.

"The new alloy and stent design of the PROMUS Element Stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy," said Dr. Stone. "I am enthusiastic about the possibility of having both everolimus and paclitaxel versions of this innovative stent system available, allowing for the tailored treatment of patients with coronary artery disease."

"Patient enrollment in the PLATINUM trial is scheduled to be completed by October," said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. "This should enable U.S. and Japanese launches of an internally developed everolimus stent -- PROMUS Element -- consistent with the expiration of our existing PROMUS supply agreement in mid-2012. We plan to launch PROMUS Element in Europe during the fourth quarter of this year."

The PLATINUM clinical program will evaluate the safety and efficacy of the PROMUS Element Stent in three studies.

The first, PROMUS PLATINUM Workhorse, will evaluate the safety and efficacy of the PROMUS Element Stent compared to Boston Scientific's PROMUS Stent. This 1:1 randomized study will evaluate 1,532 patients from 160 global sites with de novo "workhorse" lesions from 2.50 to 4.25 mm in diameter and less than 24 mm in length. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 mon
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SOURCE Boston Scientific Corporation
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