Wednesday, September 7, 2022

FDA Clears Novel, Rapid-Acting TMS System for Treatment-Resistant Depression

The Food and Drug Administration (FDA) has cleared the SAINT Neuromodulation System for the treatment of refractory depression in adults, Magnus Medical Inc. (the manufacturer of the product) announced Tuesday. SAINT is a modified form of transcranial magnetic stimulation (TMS) that compresses weeks of conventional TMS therapy into just five days.

“I am excited and humbled by the FDA’s decision and ready for the next part of SAINT’s journey,” Nolan Williams, M.D., who guided the development of SAINT, told Psychiatric News. Williams is an assistant professor of psychiatry and behavioral sciences at Stanford University, director of the Stanford Brain Stimulation Lab, and advisor for Magnus Medical. “SAINT is now the first commercially available rapid-acting neuromodulation treatment, which means it can be used in emergency and inpatient settings.”

While most current TMS protocols involve delivering stimulation to patients for between 20 minutes and 30 minutes on a single day, SAINT can deliver therapeutic doses of magnetic energy in as little as three minutes. After receiving an MRI to best target the SAINT stimulation, patients receive 10 daily sessions, spaced 50 minutes apart.

As demonstrated in a clinical trial published in The American Journal of Psychiatry, Montgomery-├ůsberg Depression Rating Scale (MADRS) scores dropped by 62% among participants following five days of SAINT stimulation compared with a 14% drop among participants receiving sham stimulation. These improvements were sustained over a four-week follow-up.

“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, Ph.D., co-founder and CEO of Magnus, in a company press release.

To read more on this topic, see The American Journal of Psychiatry article “Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial” and the Psychiatric News article “New Stanford Protocol for TMS Found to Achieve Fast Remission.”

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