FDA Panel Wants More Data on TMS

By Mechcatie, Elizabeth | Clinical Psychiatry News, February 2007 | Go to article overview

FDA Panel Wants More Data on TMS


Mechcatie, Elizabeth, Clinical Psychiatry News


GAITHERSBURG, MD. -- A noninvasive device that delivers magnetic stimulation to the brain as a patient sits in a chair alert and awake appears to be safe, but has not been proven to be an effective treatment for depression, a federal advisory panel has agreed.

At a meeting in late January, members of the Food and Drug Administration's Neurological Devices Panel did not support approval of the NeuroStar Transcranial Magnetic Stimulation (TMS) System for treating patients with major depressive disorder. The decision was based on the data presented by the manufacturer, Neuronetics.

Several panelists said they believed there was a signal for effectiveness in treating major depression in the study. Those panel members also encouraged the company to continue pursuing studies of the device in this population.

One of the panelists, Dr. Delbert Robinson, agreed that based on the data, TMS appeared to have a relatively good side effect profile. But determining whether TMS is equivalent to electroconvulsive therapy (ECT) is "obviously a struggle," said Dr. Robinson, a psychiatrist at Zucker Hillside Hospital, Glen Oaks, N.Y. "Depression is a very serious illness, and any new modalities and new ways to treat it is obviously very much desired by patients and the people treating them," he said. Dr. Robinson said he looked forward to the next round of studies and that if the TMS device does become available in clinical practice, the issue of which patients would receive it would prove crucial.

Instead of filing for approval as a new device, Neuronetics filed a "510 (k)," which requires that the device be shown to be comparable to another device on the market, with the same intended use, with clinical evidence of a comparable risk-to-benefit profile.

In this case, Neuronetics proposed that the TMS device had a comparable risk-to-benefit profile of ECT devices for treatment of major depressive disorder. …

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