FDA Permits Marketing of Stimulation Device for Treatment of Obsessive Compulsive Disorder

Officials with the FDA have given approval for marketing Brainsway’s Deep Transcranial Magnetic Stimulation (TMS) System. The device is utulized for treatment of obsessive compulsive disorder (OCD).

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” 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, in a prepared statement. “Patients with OCD who have not responded to traditional treatments now have another option.”

TMS is a procedure that utilizes magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008, and the agency expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.

The Brainsway device is contraindicated for patients with metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, and hair accessories.

During treatment with the device, the patient must use earplugs to reduce exposure to the loud sounds produced by the device. Patients with a history of seizures should discuss their history with their health care provider before receiving the device.

Read the full article at ContemporaryClinic.com.