Abbott (NYSE:ABT) announced today that it received FDA breakthrough device designation for its deep brain stimulation (DBS) system.
The breakthrough nod allows Abbott to investigate the use of its DBS system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD).
Abbott Park, Illinois-based Abbott designed its DBS system as a personalized, adjustable therapy that involves implanting thin wires (leads) into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads and produces electrical impulses that can modulate abnormal brain activity.
The company said in a news release that, while its DBS system has traditionally been used to help control symptoms for people with movement disorders, including Parkinson’s disease and essential tremor, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD.
Abbott and the FDA are working to develop a plan to evaluate the device’s safety and effectiveness for the purpose of treating TRD, with one of the benefits of certain Abbott DBS systems being that they can be used with NeuroSphere Virtual Clinic, a first-of-its-kind connected care technology that allows people to communicate with and receive care and therapy adjustments from their doctors remotely and from the comfort of their own home (with cellular or Wi-Fi connection and a sufficiently charged patient controller).
The company said that, with breakthrough designation, its investigational DBS therapy could become available as a new treatment option sooner for those affected by TRD, as devices must address an unmet need and show potential for providing more effective treatment to qualify for such 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,” Abbott VP of Neuromodulation Pedro Malha said in the news release.
