Abbott Laboratories has won breakthrough device designation for its deep brain stimulation (DBS) system to be investigated in the use of treatment-resistant depression (TRD). The Abbott Park, IL-based company’s system has traditionally been used to help control symptoms for people with movement disorders, such as Parkinson’s disease and essential tremor.
The company said evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD.
"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, neuromodulation, Abbott.
TRD represents a huge market opportunity for Abbott. The condition costs the U.S. approximately $44 billion a year in healthcare, unemployment, and lost productivity, deep brain stimulation has the potential to offer meaningful improvement of depressive symptoms.
Currently, physicians have access to a range of treatments for MDD, also called clinical depression, including antidepressant medications and device therapies. Despite this, up to a third of individuals diagnosed with MDD – about 2.8 million Americans each year – do not respond even after trying four different antidepressant regimen approaches1,2 resulting in TRD or difficult-to-treat depression. With each failed treatment, the chance of experiencing a decrease in symptoms drops. By the fourth failed treatment, as many as 83% of patients will relapse.
About two years ago, Abbott strengthened its neuromodulation prowess by receiving approval for its Infinity DBS to target an area of the brain called the globus pallidus (GPi). The GPi plays an integral role in motor function and can be targeted with DBS to improve Parkinson’s disease symptoms not adequately controlled by medication.
Abbott said the approval, the Infinity DBS is now the only directional DBS system approved for all major targets used to treat movement disorders, Parkinson's disease, and Essential Tremor: the subthalamic nucleus (STN), ventral intermediate nucleus (VIM), and GPi.