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FDA Clears Neuromodulation System for Patients With MDD
The US Food and Drug Administration has provided Magnus Medical Inc. 510(k) clearance for the SAINT Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have not achieved adequate improvement from prior antidepressant medications in the current episode.
The system uses structural and functional magnetic resonance imaging (MRI) to guide focused neurostimulation in people with MDD, according to the company. This approach is delivered on an accelerated timeline and is tailored to each person’s brain connectivity.
“This clearance expands the way we can use transcranial magnetic stimulation to treat depression,” 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.”
A double-blinded randomized controlled trial published in The American Journal of Psychiatry found that 79% of patients achieved depression remission with SAINT compared with 13% in the sham treatment arm.
”The treatment effects observed with SAINT treatment…were dramatic, rapid, and frequently sustained through the study follow-up period,” said Alan F. Schatzberg, MD, the Kenneth T. Norris Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University, and a past president of the American Psychiatric Association. “The technology could result in a fundamental change in the treatment approach to patients with refractory MDD and has the potential to reduce both the morbidity and mortality associated with the disorder.”
Magnus Medical expects the commercial launch to begin on a limited basis later in 2023. The company is currently compiling a waitlist of interested providers and patients.
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