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According to the applicant, the alternative to establishing a new category codeforcing the device into a category like C1763 or C1765would continue the current disincentive for adoption, contradicting CMS's goal of enabling access to worthwhile new therapies, whereas creating a new category code would signal to hospitals that the Axoguard HA+ Nerve Protector TM is recognized as an innovation and encourage appropriate use in patients who need it

Most of these side effects do not require medical attention and resolve gradually over time

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