FDA Grants Abbott Permission to Investigate DBS in Managing Depression

Abbott recently announced that they had been granted Breakthrough Device Designation by the FDA, which allows them to investigate the use of deep brain stimulation (DBS) in managing severe treatment-resistant depression. If this treatment is successful, it could revolutionize care for patients with treatment-resistant depression (TRD).  

The American Academy of Neurological Surgeons defines DBS as “an elective surgical procedure in which electrodes are implanted into certain brain areas. These electrodes, or leads, generate electrical impulses that control abnormal brain activity.” 

Currently, the most common use for DBS is for treating movement disorders such as Parkinson’s disease. However, according to the Cleveland Clinic, DBS is being explored in addiction, Alzheimer’s, and pain disorder treatments.  

While there are benefits and drawbacks to DBS, using DBS to manage TRD may provide a novel solution to an unaddressed issue. 

According to the Abbot announcement, “for patients who suffer from TRD, a condition that costs the US approximately $44 billion a year in healthcare, unemployment, and lost productivity, deep brain stimulation can offer meaningful improvement of depressive symptoms.” 

The CDC states that 1 in 6 adults in the United States will experience depression at some point in their life. Beyond that, 16 million adults in the US are impacted by depression annually.  

Symptoms of depression can severely alter quality of life and may be fatal if left untreated.  

The Abbot release states, “to qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions.”  

Despite this promising announcement, the use of DBS for managing TRD has a long way to go before full FDA approval, although professionals in the organization are hopeful. 

The release says, “with Breakthrough Device Designation, Abbott's DBS system could become available as a new treatment option sooner for people affected by TRD.” 

Although DBS treatment has many benefits, it is still an invasive surgical procedure. As with any surgical procedure, there are risks associated with the treatment. Patients must meet specific criteria and pass multiple clinical tests before being able to schedule the first of the two procedures.  

As mental health professionals await the results of DBS treatment in TRD, they will consider the benefits and drawbacks of using DBS as a standard of care. Should this treatment be approved for the universal treatment of TRD, patients will also have to weigh the risks with the potential for an improved quality of life.