FDA Grants Breakthrough Device Designation to Abbott’s DBS System for Severe Depression

The FDA granted a Breakthrough Device designation to Abbott’s deep brain stimulation (DBS) system for treatment-resistant depression, a form of major depressive disorder.

The DBS system uses leads that are implanted into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads to deliver electrical impulses that can modulate abnormal brain activity.

The system is already being used for patients with movement disorders such as Parkinson’s disease and essential tremor. However, Abbott says that implanting the electrodes in the part of the brain that regulates mood could help reduce symptoms of treatment-resistant depression.

The company is working with the FDA to develop a plan for evaluating the device’s efficacy and safety for this potential indication.

The agency grants Breakthrough Device designations for investigational products that address an unmet need or can provide a more effective treatment or diagnosis of life-threatening diseases or debilitating conditions.