The Food and Drug Administration (FDA) has granted 510(k) clearance for the SAINT Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode.

The SAINT (Stanford accelerated intelligent neuromodulation therapy) Neuromodulation System is an integrated hardware, software, and cloud-computing system that delivers accelerated intermittent theta-burst stimulation (iTBS). It uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm to identify the optimal anatomic target for focused neuromodulation in individuals with MDD. 

The FDA clearance was based on data from a randomized, double-blind, sham-controlled trial (ClinicalTrials.gov Identifier: NCT03068715) that evaluated SAINT in patients with treatment-resistant depression who were experiencing moderate to severe depressive episodes. Patients were randomly assigned to receive either active or sham SAINT.

At the planned interim analysis, results showed that patients treated with SAINT achieved a 52.5% mean reduction from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 4 weeks compared with an 11.1% mean reduction for patients in the sham group. Findings also demonstrated that 79% of patients in the SAINT arm entered remission from depression vs 13% of the sham arm.

“This FDA clearance of the SAINT Neuromodulation System for depression is really exciting news,” said Mark S. George, MD, distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina. “The older approaches often took 6 weeks for depression to respond, while this approach observed remission from depression in just 5 days. That opens up many new possibilities to use SAINT in hospitalized patients, for patients who present to the emergency room, and with different schedules in clinics.”

The SAINT Neuromodulation System is expected to be commercially available in late 2023 on a limited basis by prescription only.

Patients should not receive treatment with the SAINT Neuromodulation System if they have any non-removable metal material anywhere in their head or within 30cm of the stimulation device, have an active or inactive implanted device, or have a catheter, pump, or other device that may interact with stimulation.

Headache, anxiety, fatigue, and discomfort from stimulation may occur with use. Other adverse effects that have occurred with similar devices include seizure and worsening depression or suicidal thoughts.

References

  1. Magnus Medical receives FDA clearance for the SAINT Neuromodulation System for non-invasive, individualized and precise treatment of severe depression. News release. Magnus Medical. Accessed September 6, 2022. https://www.businesswire.com/news/home/20220906005228/en/Magnus-Medical-Receives-FDA-Clearance-for-the-SAINT-Neuromodulation-System-for-Non-Invasive-Individualized-and-Precise-Treatment-of-Severe-Depression
  2. Cole EJ, Phillips AL, Bentzley BS, et al. Stanford neuromodulation therapy (SNT): a double-blind randomized controlled trial. Am. J. Psychiatry. Published online October 29, 2021. doi:10.1176/appi.ajp.2021.20101429
  3. Patients and Caregivers. Magnus Medical. Accessed September 6, 2022. https://www.magnusmed.com/waitlist/patients/