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One-Year EVOLVE Trial Clinical Results Confirm Comparable Safety And Effectiveness Data Of The Boston Scientific SYNERGY™ Stent Versus PROMUS Element™ Platinum Chromium Stent
Date:5/15/2012

NATICK, Mass., May 15, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces that the SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the PROMUS Element™ Everolimus-Eluting Platinum Chromium Stent System in the EVOLVE First Human Use Trial.  The trial reported one-year clinical and six-month intravascular ultrasound (IVUS) outcomes data, evaluating the safety and effectiveness of the bioabsorbable abluminal polymer-coated SYNERGY Stent.  Results were presented today at the annual EuroPCR Scientific Program in Paris by Stefan Verheye, M.D., Ph.D., F.E.S.C., senior interventional cardiologist at the Antwerp Cardiovascular Institute, ZNA Middelheim Hospital, Belgium.

The EVOLVE trial previously reported the primary angiographic and clinical endpoints of non-inferiority of the SYNERGY Stent compared with PROMUS Element for late loss at 6 months and target lesion failure (TLF) at 30 days.  The EVOLVE one-year trial data demonstrated that both versions of the SYNERGY Stent (loaded with both full- and half-dose everolimus) are clinically non-inferior to the PROMUS Element Stent.  There were no significant differences between groups for all IVUS parameters evaluated at 6 months, including neointimal area, stent or lumen area, net volume obstruction, incomplete stent apposition or minimum lumen diameter.

"The 6-month IVUS data suggest that anti-restenotic activity is maintained with the SYNERGY stent, even after four months, when the drug and polymer coating are designed to be absorbed. Importantly, the SYNERGY Stent has shown equivalent clinical safety and effectiveness in the EVOLVE data compared to the PROMUS Element Stent.  We continue to observe very low rate
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SOURCE Boston Scientific Corporation
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