Approving the Vagus-Nerve Stimulator for Depression

Abstract

The vagus-nerve stimulator (VNS), a device that is implanted by a neurosurgeon and sends intermittent electrical pulses to the brain, has been marketed in the United States since 1997 as an adjunctive therapy for the control of epilepsy. Debate is ongoing, however, over the use of the device in patients with refractory depression. Though the key clinical questions (Does it work? Is it safe?) seem straightforward, answering them is proving rather complicated. The Food and Drug Administration (FDA) approved the use of the VNS for depression in 2005, but in February 2007, the Centers for Medicare and Medicaid Services issued . . .