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Boston Scientific SYNERGY™ Stent Demonstrates Comparable Safety and Effectiveness Outcomes Versus PROMUS Element™ Platinum Chromium Stent
Date:11/11/2011

NATICK, Mass. and SAN FRANCISCO, Nov. 11, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports results from the EVOLVE First Human Use trial demonstrating the non-inferiority of the SYNERGY™ Everolimus-Eluting Stent System compared to the PROMUS Element™ Everolimus-Eluting Stent System in treating de novo coronary artery lesions.  The trial provided 30-day clinical and six-month angiographic primary endpoint data evaluating the safety and effectiveness of the bioabsorbable polymer-coated SYNERGY Stent.  Results were presented today during a late-breaking clinical session by Professor Ian T. Meredith, M.B.B.S., Ph.D., Director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and Principal Investigator of the trial, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

The prospective, randomized, single-blind, non-inferiority trial enrolled 291 patients at 29 sites in Europe, Australia and New Zealand.  Patients were randomized to either one of two dose formulations of everolimus used on the SYNERGY Stent, which employs an ultra-thin abluminal bioabsorbable polymer, or to the commercially available PROMUS Element Stent, which employs the everolimus drug and a permanent durable polymer.  One formulation of the SYNERGY Stent used an everolimus dose and release profile similar to the PROMUS Element Stent, while the second formulation of the SYNERGY Stent used a similar release profile but half the dose of everolimus.

"The SYNERGY Stent met the primary non-inferiority endpoint of six-month late loss compared to the PROMUS Element Stent, demonstrating effectiveness of drug elution from this abluminal bioabsorbable polymer," said Dr. Meredith.  "The platform also appears to be safe with very low rates of myocardial infarc
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