FDA grants breakthrough designation to transcranial magnetic stimulation device for bipolar depression
The FDA granted breakthrough device designation to the NeuroStar Advanced Therapy System for the treatment of bipolar depression, according to a press release from Neuronetics Inc., the device’s manufacturer.
The system uses transcranial magnetic stimulation (TMS), a noninvasive form of neuromodulation, to stimulate areas of the brain that are underactive in depression. It is the first TMS device to receive the breakthrough device designation for bipolar depression. The designation applies specifically to adult patients with bipolar I or II disorders who failed to show satisfactory improvement with prior pharmacological therapy.
“Bipolar disorder affects approximately 6.5 million to 7 million U.S. adults annually,” Yelena Tropsha, PhD, vice president of commercial access for Neuronetics Inc., told Healio Psychiatry. “Of them, approximately 61% receive an accurate and formal diagnosis. NeuroStar will target patients actively treated for the depressive phase for whom current pharmacological treatment options are failing, which we estimate to be approximately 480,000 U.S. patients annually.”
In 2008, the system became the first TMS device to receive FDA clearance for adults with major depressive disorder who had not seen success with at least one antidepressant medication.
According to Tropsha, prior therapies typically have focused on treating the mania and hypomania phase of bipolar disorder, and only a few medications have been approved for the depression phase. With this designation, the NeuroStar may provide more effective treatment to this patient population with limited safety concerns, Tropsha said.
“Neuronetics is working with the FDA on the clinical protocol, so the timing is still to be determined to begin enrollment for a clinical trial in bipolar depression,” Tropsha told Healio Psychiatry. “NeuroStar is currently FDA-cleared for unipolar major depression in adults and is widely available throughout the country. Since receiving FDA clearance in 2008, over 75,000 patients with depression have been treated with NeuroStar, with over 2.5 million treatments performed. NeuroStar for depression is covered by most major insurance providers, including Medicare and Tricare.” – by Joe Gramigna
Disclosures: Tropsha is an employee of Neuronetics Inc.