The company had originally applied for CMS approval in 2007, but the agency rejected the application at that time. Cyberonics had hoped that additional evidence over the last five years supporting VNS's efficacy in depression treatment would lead CMS administrators to reverse their earlier decision, but that did not happen. Cyberonics is hopeful that VNS Therapy will eventually gain that approval, with CEO Dan Moore saying that "The company plans to work with other interested parties to continue to pursue access to this important therapeutic option...." The VNS system has already been approved by the Food and Drug Administration for use in patients with treatment-resistant depression and with epilepsy patients. CMS has approved reimbursement for its use in Medicare beneficiaries with refractory epilepsy.
To read about the earlier regulatory decisions regarding VNS, see Psychiatric News.
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