On July 12, 2022 Abbott announced that the FDA has granted Breakthrough Device Designation for its plan to investigate the use of its deep brain stimulation (DBS) system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD). It is important to emphasize TRD implies patients who have failed to respond to conventional therapies, namely drugs. These are precisely the types of patients for whom new interventions, such as brain stimulation, must be developed. The FDA Breakthrough Device Designation is intended to expedite the review process for technologies considered innovative and addressing irreversibly debilitating diseases. This news represents an important milestone in Abbott re-investment in DBS for MDD. Abbott acquired a its DBS program through its acquisition of St Jude Medical in 2017. This followed the setback in DBS for MDD when St. Jude Medical failed a futility analysis of its BROADEN trial of DBS for treatment of depression, which followed highly encouraging pilot clinical trials led by Dr. Helen Mayberg and colleagues. However, as Dr. Mayberg and others have explained regarding the BROADEN trial that both the method of dosing DBS (precise placement and programmed of DBS electrodes) and patient engagement was not optimal, such that lessons learned support ongoing clinical trials. This includes using advanced MRI patient scanning techniques, such as tractography, to identify key nerve tracks to stimulate (for example see computational dose optimization work by Dr. Cameron McIntyre, a collaborator of Dr. Mayberg).
Continuing with the theme of brain stimulation that is individually targeted based on brain scans, a team led by Dr. Nolam Williams developed the Stanford accelerated intelligent neuromodulation therapy (SAINT) TMS therapy for depression. Transcranial Magnetic Stimulation (TMS) is already and established therapy for certain depression disorders (see Neuromodec’s index of FDA approved systems). But Dr. Williams and team proposed and tested an innovative TMS treatment that uses bran scanning to identify the optimal anatomic stimulated targets for TMS based on brain connectivity, as well as an accelerated timeline for the therapy. The technology is commercialized through Magnus Medical which received FDA Clearance for the SAINT Neuromodulation System in September 2022. Two prior FDA cleared systems for TMS treatment for depression that used brain scans are made by Finland based Nexstim and US based Soterix Medical.
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