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Early Coronary Artery Healing Advantage of OrbusNeich's Combo Dual Therapy Stent™ Compared to the TAXUS® Stent Shown in Two Clinical Trial Subgroup Analyses
Date:5/17/2012

PARIS, May 17, 2012 /PRNewswire/ -- OrbusNeich today announced that two subgroup analyses from the REMEDEE trial assessing vascular healing of the company's Combo Dual Therapy Stent versus the TAXUS paclitaxel-eluting stent demonstrate an early advantage with the Combo Stent.  Presented at EuroPCR 2012, the data were obtained with frequency-domain optical coherence tomography (FD-OCT) and virtual histology-intravascular ultrasound (VH-IVUS) at nine-month follow-up.

An independent OCT core laboratory performed a blinded quantitative analysis of the percent strut coverage and in stent neointimal characteristics along with a qualitative assessment of neointimal tissue appearance and make-up of 23 Combo Stents and 10 TAXUS stents at nine-month follow-up.

Specifically, the data show that neointimal volumes and thicknesses as measured with OCT were comparable at nine months post-implantation for both the Combo Stent and TAXUS stent as determined by a blinded OCT core lab analysis. However, the qualitative analysis inside the stent showed a more homogenous neointimal tissue appearance in the Combo Stent compared to the TAXUS stent. In detail, the Combo Stent placements had statistically significant more homogeneous tissue appearance compared to the TAXUS stent placements (79.2% versus 40%).  Heterogeneous and layered tissue appearance was observed in 60% of the TAXUS stent placements and in 20.8% of the Combo Stent placements. Additionally, there were fewer microvessels and macrophage-like appearances inside the Combo Stent compared to the TAXUS stent: 8.3% versus 30% microvessels; 4.2% versus 10% macrophage-like appearances.

"These intriguing data possibly demonstrate a more homogenous tissue appearance with the Combo Stent versus a more heterogeneous appearance with the TAXUS stent in a blinded analysis," said Akiko Maehara, M.D.,director of Intravascular Imaging Core Laboratory at the Cardiovascular Research Foundation and assistant pro
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