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Comment: The applicant submitted a response to our concerns that some components or parts of the aprevo Cervical ACDF System, specifically the aprevo insertion instrument, the integrated fixation screws, and/or the CAM, may be considered a material or supply furnished incident to the service, because, as previously discussed with respect to criteria at 419.66(b)(3), it is unclear how and when these components or parts are used, and whether they can be substituted with other products

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Molecular pathways documented in preclinical research include: (1) activation of nitric oxide (NO) synthesis via L-arginine/eNOS pathway, (2) transcriptional upregulation of VEGF-A and FGF-2 favouring angiogenesis, (3) modulation of the Egr-1 early transcription factor involved in fibroblast proliferation, (4) interaction with 5-HT2A and dopaminergic receptors in some behavioural models, (5) stabilisation of endothelial function via eNOS modulation and reduction of oxidative stress (8-OH-dG, MDA)

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