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Implant Device for Depression May Soon Gain FDA Approval

May 24, 2005 |

Although many experts maintain there is little evidence that the device actually works, the FDA may soon approve a "vagus nerve stimulator" manufactured by Cybertronics, Inc., for the treatment of severe depression. The pacemaker-like device, which costs $15,000, is designed to be surgically implanted in the upper chest and wired to the vagus nerve leading to the brain.

Although the stimulator has been approved for the treatment of some epilepsy patients since 1997, the FDA has told the manufacturer that the device is "approvable" for use as a treatment for otherwise unresponsive cases of severe depression. While proponents of the device claim that it will provide a viable option to patients who have not responded to traditional therapies or medication, critics point to trial results which showed that the stimulator when turned on was no more effective than when it was implanted and turned off.

Public Citizen is wary of an "epidemic of implantation of a device with no proven effectiveness" and aggressive marketing that leads to doctors prescribing it for moderate depression.

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