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Gan et al observed thickened myelin sheath and increased cross-sectional area of target muscle cells after daily mecobalamin administration intraperitoneally in rats with sciatic nerve injury 15

As an example, the applicant cited language from the Uretero1 TM decision in which CMS agreed that the device met the criterion for substantial clinical improvement, which stated that while comparative studies between Uretero1 TM and other disposable devices would be helpful, CMS agreed that the evidence demonstrating improved outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represented substantial clinical improvement (87 FR 71932)

This is particularly relevant for rotator cuff injuries, where the damaged structure is largely tendinous

Available: [12] M