FDA grants clearance to TMS device for MDD in young people

The FDA has granted clearance to a transcranial magnetic stimulation device as an adjunctive treatment for major depressive disorder in patients aged 15 to 21 years, according to the manufacturer.

In a press release, medical technology firm Neuronetics Inc. announced that its NeuroStar Advanced Therapy will be the first and only such treatment cleared for this specific age group.

The FDA’s decision was based in part on analyzing real-world data collected through NeuroStar's proprietary TrakStar platform, according to the release. The analysis included 1,169 adolescents, 78% of whom achieved “clinically meaningful” improvement in their depression severity following use of the device.

Upon review of TrakStar’s data set as well as clinical data from existing literature, the FDA concluded that the safety and efficacy of NeuroStar TMS was “substantially equivalent” when used as an adjunct to antidepressant therapy over antidepressant therapy alone for the adolescent to young adult population, per the release.

“Each year, nearly one in five adolescents in the U.S. experiences at least one major depressive episode and now, for the first time, they have an alternative to drug therapy alone,” Neuronetics President and CEO Keith J. Sullivan told Healio in an email. “Nearly 10,000 adolescents have been treated with over 300,000 NeuroStar sessions to date, and with this clearance, we are excited to expand NeuroStar TMS to many more who can benefit from this treatment.”