FDA grants clearance to TMS device, NeuroStar as adjunct to first line depression treatment

The US Food and Drug Administration has cleared first transcranial magnetic stimulation (TMS) device, NeuroStar, adjunct to first-line treatment of major depressive disorder for individuals aged 15 to 21.

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.

"The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic. The current treatment options available for adolescents are extremely limited, compared to those available for adults," according to Dr. Kenneth Pages, Medical Director of TMS of South Tampa. "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults. This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."

The FDA's decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar's proprietary TrakStar® platform. This platform provided crucial insights into the treatment's effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity. The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.