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Magnus Medical Receives FDA Clearance for the SAINT Neuromodulation System for Non-Invasive, Individualized and Precise Treatment of Severe Depression

Devices for Depression Aim for a Network Effect

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The SAINT® Neuromodulation System is indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. The SAINT Neuromodulation System is contraindicated for: patients with non-removable conductive, ferromagnetic, or other magnetic-sensitive metal anywhere in the head or within 30cm of the stimulation coil; patients who have an active or inactive implanted device; or patients with increased intracranial pressure or intracardiac lines, intravenous pumps, or dose calculators. Consult product labeling for a complete list of contraindications, warnings, and precautions. Side effects including headache, fatigue, anxiety, and treatment-site discomfort were shown in clinical trials. Risks associated with transcranial magnetic stimulation, including seizure and worsening depression or suicidality, may exist. Results may vary.

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