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Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
Date:10/8/2008

the TAXUS Element Stent System incorporates new balloon technology, intended to improve on Boston Scientific's market-leading Maverick(R) Balloon Catheter platform.

"The new alloy and stent design of TAXUS Element provides improved deliverability and visibility, even in patients with complex and challenging anatomy," said Dean J. Kereiakes, M.D., Medical Director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati and the principal investigator for the trials. "I am very enthusiastic about the potential the TAXUS Element Stent offers me to treat a broader range of patients."

The TAXUS PERSEUS clinical program will evaluate the efficacy and safety of the TAXUS Element Stent in two studies.

The first study, TAXUS PERSEUS Workhorse (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions), will evaluate the safety and efficacy of the TAXUS Element Stent compared to Boston Scientific's first generation drug-eluting stent, the TAXUS(R) Express(TM) Stent. This 3:1 randomized study will evaluate 1,264 patients from 94 sites in the U.S., Australia, New Zealand and Singapore with "workhorse" lesions from 2.75 to 4.0 millimeters in diameter. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 months, and its secondary endpoint is in-segment percent diameter stenosis at nine months.

A second parallel study named the TAXUS PERSEUS Small Vessel study will compare the TAXUS Element Stent to a historic control (TAXUS V de novo bare-metal Express(R) Coronary Stent System). This study will include 224 patients from 35 U.S. sites with lesions from 2.25 up to 2.75 millimeters. The primary endpoint of the small vessel study is in-stent late loss at nine months, and its secondary endpoint is TLF at 12 months.

The TAXUS Element Stent is an
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SOURCE Boston Scientific Corporation
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