Abbott will work with the FDA to expedite the review of their deep brain stimulation system to treat the life-threatening disease of treatment-resistant depression.
Abbott was granted Breakthrough Device Designation by the FDA to investigate its deep brain stimulation (DBS) system for patients with treatment-resistant depression (TRD).1,2
The DBS system uses an implant embedded in the skin underneath the chest connected to thin wires (leads).1 The implant generates electrical pulses that run through the wires, which are connected to targeted areas of the brain.1
To reduce TRD symptoms, promising evidence suggests that leads would be implanted in the mood-regulating part of the brain to modulate abnormal brain activity.1
Abbott’s DBS system is currently used to control symptoms of movement disorders, including Parkinson disease and essential tremor.1
The Breakthrough Device Program aims to accelerate the development, assessment, and review of quality standards for breakthrough device technology, allowing it to receive pre-market approval and more quickly become an available treatment option.1
For a specific device technology to qualify for the designation, it must address an unmet need and show the potential to provide effective treatment for life-threatening diseases and debilitating, irreversible conditions.1
"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, Abbott vice president, neuromodulation, in a press release.
TRD is a form of major depressive disorder (MDD) that costs $44 billion in health care, unemployment, and lost productivity every year.1 Current treatment options for MDD include antidepressant medications, devices therapies, and other approaches.1
Nearly 2.8 million Americans do not respond to these traditional treatment options though, which leads to TRD. This condition progressively worsens with each failed treatment regimen and patients are more likely to experience persistent symptoms. Up to 83% of people will relapse after 4 failed therapies.1
Some Abbott DBS systems can be used with NeuroSphere Virtual Clinic, which provides an additional benefit for patients who want to communicate, receive care, and make therapy adjustments with doctors virtually.1
Treating TRD is limited to investigational use only under the Breakthrough Development Program.Abbott is currently developing a plan with the FDA to evaluate the safety and efficacy of using the device to treat TRD, and it is not yet available on the market.1