FDA Grants Approval for Brainsway’s OCD-Treating TMS System

August 22, 2018  Source: Mass Device 353

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Obsessive-compulsive disorder (OCD) patients are now offered with a new treatment option as the FDA grants de novo approval for Brainsway’s deep transcranial magnetic stimulation (TMS) system.

Stimulating nerves inside the brain using magnetic fields, the TMS system has shown to mitigate the severity of OCD in patients.

A randomized, multi-center study comprising of 100 patients using the device revealed that patients who underwent TMS treatment in conjunction with medical management showed a 38% increased response rate, compared to those treated with a placebo device and medical management, showing an 11% response rate.

Common side effects included headaches, which was accounted for by 37.5% of patients managed with the Brainsway device and 35.3% of patients managed with placebo treatment. Grave adverse events were absent and other unfavorable reactions like application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain were noted as mild or moderate and disappeared soon after treatment, the FDA observed.

The Brainsway device is contraindicated in patients having metallic substances or carrying implanted stim devices inside or adjacent to the head.

Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches. With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” FDA Center for Devices and Radiological Health Division of Neurological and Physical Medicine Devices director Carlos Peña said in a press release.

By editor
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