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Instent Restenosis and Late Stent Thrombosis - page 31 / 35

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December 2006 FDA Findings

The panel was in general agreement that DES, when used in accordance to their FDA approved labeled indications, are associated with a clinically important numerical excess of late stent thromboses (after 1 year post-implantation) compared to BMS; however, the magnitude of this excess is uncertain and additional data are needed.

The panel reached consensus that the DES safety concerns do not outweigh their benefits compared to BMS when used within the limits of the approved labeling.

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