Magnus Medical has announced receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for its 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.
“Magnus’ SAINT technology is groundbreaking and could help many patients with MDD who have not responded to treatment with antidepressants,” said Alan Schatzberg (Stanford University, Stanford, USA). “The treatment effects observed with SAINT treatment in the double-blinded randomised controlled trial [RCT] 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 US FDA clearance of the SAINT neuromodulation system for depression is really exciting news,” added Mark George (Medical University of South Carolina, Charleston, USA). “This is more than just clearance of another device. This clearance expands the way we can use TMS [transcranial magnetic stimulation] 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 hospitalised patients, for patients who present to the emergency room, and with different schedules in clinics.”
The American Journal of Psychiatry published results from a double-blinded RCT evaluating SAINT last year, showing that 79% of people in the active treatment arm entered remission from their depression compared to 13% in the sham treatment arm.
The SAINT neuromodulation system, which previously received Breakthrough Device designation from the FDA, is a novel innovation that is significantly impacting the treatment of severe depression, according to a Magnus press release. For the first time, advanced imaging technologies combined with personalised targeting and novel stimulation patterns have yielded a new form of individualised neurostimulation for people with treatment-resistant depression.
“We expect the commercial launch of our SAINT neuromodulation system to begin later in 2023 on a limited basis, for which we are building a waitlist and engaging with an overwhelming number of teaching institutions, hospitals, clinics, interested clinicians, and medical professionals,” said Brett Wingeier, co-founder and CEO of Magnus.
SAINT uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD. This new approach is delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity, the release notes.