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  2. Abbott Receives FDA's Breakthrough Device ... - Abbott MediaRoom

    abbott.mediaroom.com/2022-07-12-Abbott-Receives-FDAs-Breakthrough-Device...

    Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression (TRD) With Breakthrough Device Designation, Abbott's deep brain stimulation (DBS) System could become available as a new treatment option sooner for people affected by TRD.

  3. Abbott Initiates Clinical Study to Evaluate the Use of Its Deep...

    abbott.mediaroom.com/2024-09-04-Abbott-Initiates-Clinical-Study-to-Evaluate...

    The U.S. FDA granted Abbott Breakthrough Device designation to explore deep brain stimulation (DBS) for treatment-resistant depression (TRD) as an option to improve the lives of people with this debilitating condition.

  4. Brain Stimulation Therapies - National Institute of Mental ... -...

    www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation...

    Similarly, DBS received Breakthrough Device Designation from the FDA in 2022 to investigate its use for treatment-resistant depression. A systematic review and meta-analysis showed favorable effects of DBS in treating depression symptoms.

  5. A pacemaker that helped a woman with depression may soon be...

    apnews.com/article/treatmentresistant-depression-dbs-deep-brain-stimulation...

    Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It’s approved for conditions such as Parkinson’s disease and epilepsy, and many doctors and patients hope it will become more widely available for ...

  6. Precision Deep Brain Stimulation Shows Initial Promise for Severe...

    directorsblog.nih.gov/2021/11/04/precision-deep-brain-stimulation-shows...

    They then customized an FDA-approved DBS device to respond only when it recognized those specific patterns. Called NeuroPace® RNS®, the device includes a small neurostimulator and measures about 6 by 3 centimeters, allowing it to be fully implanted inside a person’s skull.

  7. Deep brain stimulation (DBS) has emerged as a promising treatment for select patients with refractory major depressive disorder (MDD). The clinical effectiveness of DBS for MDD has been...

  8. New Study Initiated to Evaluate Use of Deep Brain Stimulation for...

    www.psychiatrictimes.com/view/new-study-initiated-to-evaluate-use-of-deep...

    Investigators initiated a pivotal clinical trial, the TRANSCEND study, to evaluate the use of Abbott’s deep brain stimulation (DBS) system to manage treatment-resistant depression (TRD). The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Abbott’s DBS for TRD. 1

  9. Abbott gets FDA breakthrough tag for deep brain stimulation...

    www.medtechdive.com/news/abbott-breakthrough-deep-brain-stimulation-depression/...

    Abbott has identified treatment-resistant depression as an opportunity to expand use of its DBS system. Working with the FDA, the company will develop a plan for evaluating the safety and efficacy of the system in patients with depression.

  10. Deep Brain Stimulation System May Help Manage Severe Depression

    www.pharmacytimes.com/view/deep-brain-stimulation-system-may-help-manage...

    Abbott was granted Breakthrough Device Designation by the FDA to investigate its deep brain stimulation (DBS) system for patients with treatment-resistant depression (TRD). 1,2 The DBS system uses an implant embedded in the skin underneath the chest connected to thin wires (leads). 1 The implant generates electrical pulses that run through the ...

  11. Scientists achieve a remarkable breakthrough for treatment...

    www.inverse.com/mind-body/deep-brain-stimulation-depression-treatment

    Esketamine, a ketamine-derived drug, was approved in 2019 by the FDA for treatment-resistant depression when used in conjunction with an oral antidepressant. In 2020 it was approved for adults...