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July 24, 2006
 Cyberonics Formal Request to CMS to Consider VNS for TRD
Cyberonics, Inc., has requested that the Centers for Medicare and Medicaid
Services reconsider the existing National Coverage Decision
160.18 and add the Cyberonics' vagus nerve stimulation (VNS) device
as covered durable medical equipment for patients diagnosed with
treatment resistant depression (TRD).
Support for this request includes the July 15, 2006, U.S. Food and
Drug Administration expansion of indications for use of VNS therapy
for patients with TRD. Also, cited are results of a seven-year
clinical trial program in which the Center for Devices and
Radiological Health concluded that VNS therapy was safe and
effective in accordance with requirements for approval of a Class
III medical device.
Cyberonics proposes that if VNS therapy for TRD is compared to other
antidepressant remedies for TRD, the VNS device will provide cost
savings due to the health care utilization and disability patterns
of those with TRD. Cyberonics proposes that because the VNS device
is a durable treatment, that patients with TRD will be able to avoid
chronic disability.
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