FDA Grants Breakthrough Device Designation to Investigate Deep Brain Stimulation System in TRD

The US Food and Drug Administration (FDA) recently granted Abbott a breakthrough device designation to investigate the use of its deep brain stimulation system for patients with treatment-resistant depression (TRD), a form of major depressive disorder. The company is working with the FDA to develop a plan for evaluating the safety and effectiveness of the technology for the condition.

Already used to help control symptoms in people with movement disorders, such as Parkinson’s disease and essential tremor, Abbott’s deep brain stimulation system involves the implanting of thin wires, also called “leads,” into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads and sends electrical impulses to modulate abnormal brain activity. 

Related: TMS Guided by EEG Eases Major Depression in Half the Session Time

Evidence suggests that implanting electrodes into the part of the brain that regulates mood could help ease treatment-resistant depression. The breakthrough device designation speeds up FDA review of innovative technologies that could improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions. With the designation, Abbott’s deep brain stimulation system could become a new treatment option for people with treatment-resistant depression sooner. 

“Breakthrough product development always requires bold thinking and collaboration, and Abbott is fully committed to the journey of providing people with new therapeutic options for their treatment-resistant depression," said Pedro Malha, vice president of neuromodulation at Abbott.

Reference

Abbott receives FDA's breakthrough device designation to explore use of deep brain stimulation to manage severe depression. News release. Abbott; July 12, 2022. Accessed July 29, 2022.