HomeNewsTMS System Cleared to Deal with Obsessive Compulsive Dysfunction
Posted in News on 18th August 2018
The Brainsway device was reviewed under the FDA de novo premarket review pathway

The Brainsway device was reviewed under the FDA de novo premarket review pathway

The Food and Drug Administration (FDA) has granted marketing clearance for the Brainsway Deep Transcranial Magnetic Stimulation System (Brainsway) for the treatment of obsessive compulsive disorder (OCD). 

OCD is commonly treated with medication and/or psychotherapy but some patients continue to experience symptoms. Transcranial magnetic stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain. The FDA previously permitted marketing of TMS to treat major depressive disorder in 2008 and for pain associated with certain migraine headaches in 2013. 

The approval was based on data from a multicenter study (N=100) that randomized patients to the Brainsway device or a sham device. Study patients who were receiving pharmacologic therapy for OCD were maintained at their existing doses throughout the study. Researchers examined the reduction in patients’ Yale-Brown Obsessive Compulsive Scale (YBOCS) score. a common measure of OCD severity. 

Results showed that 38% of patients responded to the Brainsway device vs 11% of patients who responded to the sham device; response was defined as >30% reduction in the YBOCS score. Headache was the most commonly reported adverse effect (37.5% in Brainsway group and 35.3% in sham device group). No serious adverse reactions related to the Brainsway device were observed. 

The Brainsway device was reviewed under the FDA de novo premarket review pathway intended for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence. 

“With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” said Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

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