BURLINGAME, Calif. — (BUSINESS WIRE) — Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, today announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the SAINTTM 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.
“Magnus’ SAINT technology is groundbreaking and could help many patients with major depressive disorder (MDD) who have not responded to treatment with antidepressants,” said Alan F. Schatzberg, M.D., the Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University, and a Past President of the American Psychiatric Association. ”The treatment effects observed with SAINT treatment in the double-blinded, randomized controlled trial that was published in the American Journal of Psychiatry were dramatic, rapid, and frequently sustained through the study follow-up period. 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.”
“This FDA clearance of the SAINT Neuromodulation System for depression is really exciting news,” said Mark S. George, M.D., distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina. “This is more than just clearance of another device. This clearance expands the way we can use TMS to treat depression. The older approaches often took six weeks for depression to respond, while this approach observed remission from depression in just five 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.’’