TMS Device NeuroStar Cleared as Add-On Treatment for Adolescent Depression

The Food and Drug Administration (FDA) has cleared NeuroStar^® Advanced Therapy for use as an adjunct in the treatment of major depressive disorder (MDD) in patients 15 to 21 years of age. 

NeuroStar Advanced Therapy is a transcranial magnetic stimulation system that uses magnetic fields to induce neural activity in the cerebral cortex. The system consists of an electromagnetic coil, a neurostimulator to generate the electrical stimulus for the coil, a cooling system, a positioning device, and software to control the device. Treatment is performed in an outpatient setting.

The Company 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, which included 1169 adolescents. Findings showed 78% of patients achieved clinically meaningful improvement in their depression severity. 

According to Neuronetics, data from TrakStar along with published literature showed NeuroStar TMS was “substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone,” supporting approval for this patient population.

“Receiving FDA clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in.”