TMS Device NeuroStar Cleared for Anxious Depression

The Food and Drug Administration (FDA) has cleared NeuroStar^® Advanced Therapy for Mental Health for the treatment of anxiety symptoms in adults with major depressive disorder (MDD), also known as anxious depression.

NeuroStar is a transcranial magnetic stimulation system that uses magnetic fields to induce neural activity in the cerebral cortex. The device was previously approved for use in patients with major depressive disorder (MDD) who failed to receive satisfactory improvement from prior antidepressant medication in the current episode and was recently cleared to treat obsessive-compulsive disorder.

“Many people suffering from MDD also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide,” said Keith J. Sullivan, President and CEO of Neuronetics Inc. “This new indication means providers can now describe to MDD patients the benefit of NeuroStar for improving their anxiety symptoms.”

Neuronetics uses a proprietary cloud-based software, TrakStar, to remotely activate the new treatment protocol for trained providers. The clearance was based on real-world data from the TrakStar platform that included patients from over 1000 centers.

Results showed that among 664 patients with anxious depression, 65.5% achieved a clinically meaningful response which exceeded the overall study success criteria of at least 50% response rate (P <.0001).

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