Brain Devices > Article

First they said yes to VNS, then no, then yes. And now they’re trying desperately to explain their final answer.

VNS (vagus nerve stimulation) was initially developed and approved for treatment-refractory epilepsy. Cyberonics conducted one sham-controlled study for treatment-resistant depression, and while this double-blind study showed no statistical benefit over placebo, an open-label extension showed enough benefit to impress someone at the FDA. In a controversial decision in which the unanimous rejection of an advisory panel was overturned, the FDA approved VNS for treatment-resistant depression on July 15, 2005.

The last time we took a close look at transcranial magnetic stimulation (TMS) was three years ago (TCPR, Jan 2005), and we concluded that it had promise as a treatment for major depression. In that article, we reported that the company making the device, Neuronetics, would apply for FDA approval as early as Fall of 2005, and that we could be passing magnetic coils over our patients’ heads as early as 2006.

One year ago we reviewed the status of transcranial magnetic stimulation for depression, and concluded with the following TCPR Verdict: “TMS for depression: Approval is highly unlikely.” We were wrong. On October 10, 2008, the FDA approved the Neuronetics Neurostar TMS machine for the treatment of patients with major depression who have failed one prior antidepressant trial. Did they make the right decision?