FDA Grants Breakthrough Device Tag To Abbott’s DBS System

On July 12, 2022, the FDA awarded Breakthrough Device Designation to Abbott’s deep brain stimulation (DBS) device developed to care for treatment resistant depression (TRD). The Breakthrough Devices Designation program was developed to help patients gain timely access to innovations without putting the patients at risk. The program has helped expedite several innovative technologies that help provide a better quality of life to patients with severe illnesses and diseases.

Typically, Abbott’s DBS device is used to treat movement symptoms of patients’ neurological disorders such as Parkinson’s disease and essential tremor. However, recent evidence indicates that the device may be used to regulate mood and could help reduce the impact of TRD-affected individuals. The DBS system consists of a pulse generator that is implanted on a patient’s chest under their skin. The device is connected to the brain by thin wires attached to specific parts of the brain. Electrical impulses are sent to hinder and regulate signals to the brain that cause irregularities. The system is designed to provide personalized and adjustable therapy through a remotely controlled Virtual clinic technology and will require a cellular or Wi-Fi connection.

TRD is diagnosed to individuals whose depressive disorder can not be treated by at least four separate antidepressant procedures. TRD is believed to cost the U.S. up to $44 billion annually in healthcare and unemployment. Physicians can currently provide a variety of treatments to individuals with clinical depression, including antidepressant medications and device therapies. According to Abbott, up to 2.8 million people in the U.S. annually fail to respond to these treatments.  

Pedro Malha, the vice president of the neuromodulation department in Abbott, has stated Abbott’s appreciation of the designation, “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.”