Abbott’s Looks to Treat Depression With Breakthrough Device Status

Abbott has announced that its deep brain stimulation (DBS) system has been granted US FDA Breakthrough Device Designation for treatment-resistant depression (TRD), a form of major depressive disorder. Breakthrough Device status helps speed up the regulatory review process, possibly giving patients earlier access to Abbott’s DBS system. 

“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.

Related article: Alleviating Depression and Dementia with Transcorneal Electrical Stimulation

A Neurosurgical Solution to Depression

Each year, 2.8 million Americans will fail multiple depression treatments and be diagnosed with TRD. The condition is thought to cost the US an estimated $44 billion a year in healthcare, unemployment, and lost productivity. 

DBS is under investigation as a possible treatment for TRD when antidepressants and other device therapies fail. Abbott’s system is designed to be adjusted to the individual’s needs, and involves implanting thin wires called leads into target areas in the brain. The leads are connected to a pulse generator implanted under the skin in the chest, which will produce electrical impulses to modulate abnormal brain activity. 

Abbott’s DBS system has been used in Parkinson’s disease, in which implanted leads regulate abnormal neurons that cause tremor. For TRD, the company has found that implanting electrodes in the part of the brain that regulates mood may reduce disease symptoms. Abbott is now working with the FDA to evaluate the device’s safety and effectiveness for TRD. 

An additional benefit of the system is the ability to be used with Neurosphere Virtual Clinic, a remote platform that allows patients to communicate and receive care from their doctors, all from the comforts of home.

Author

Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless