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After consideration of the public comments we received and our review of the application, we have determined that the LithoVue TM Elite System meets the newness criterion at 419.66(b)(1)

Interestingly, the presentation of DAPT and BMS appeared to exert the opposite action to TB-500, suggesting that the Notch/NF-B pathways may mediate TB-500s proposed action on angiogenesis