FDA Grants TMS Device Breakthrough Designation for Bipolar Depression

Megan Brooks

March 06, 2020

The US Food and Drug Administration (FDA) has granted breakthrough device designation for NeuroStar Advanced Therapy (Neuronetics Inc) transcranial magnetic stimulation (TMS) system for the treatment of bipolar depression.

In 2008, NeuroStar Advanced Therapy System became the first TMS device to receive FDA clearance for adults with drug-resistant major depressive disorder (MDD). 

In 2017, the FDA cleared a next-generation NeuroStar Advanced Therapy device, as reported by Medscape Medical News.

NeuroStar Advanced Therapy is a noninvasive form of neuromodulation that uses magnetic pulses to stimulate areas of the brain that are underactive in depression. It is now the first TMS device to receive breakthrough designation for drug-resistant bipolar depression in adults with bipolar I or bipolar II disorders, the company said in a news release.

Bipolar disorder causes recurrent, dramatic shifts in mood, energy, and activity levels. The disorder affects about 6.5 to 7 million adults annually in the US.

The FDA's breakthrough device program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Breakthrough designation opens an expedited pathway for prioritized FDA review of the NeuroStar Advanced Therapy clinical trial program. Neuronetics has submitted initial clinical plans for discussion with the FDA.

"We are delighted that the FDA has accepted our application for Breakthrough Device Designation and look forward to working closely with them to provide a potential solution for people with bipolar depression," Yelena Tropsha, PhD, vice president of commercial access at Neuronetics, said in the release.

"This potential new treatment indication for NeuroStar means that millions of people with bipolar disorder who do not respond to medications may have a proven, non-drug treatment available to them," she added.

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