Israel-based company BrainsWay has received clearance from the US Food and Drug Administration (FDA) to market its Deep Transcranial Magnetic Stimulation (TMS) System for treating obsessive-compulsive disorder (OCD) in adults.
OCD is a common, chronic disorder characterised by uncontrollable, reoccurring thoughts and repetitive behaviours. Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to stimulate nerve cells in the brain.
The FDA cleared TMS as a treatment for major depression in 2008. In 2013, the indication has been expanded to treat pain caused due to certain migraine headaches.
The BrainsWay Deep TMS device is said to safely and efficiently provide direct stimulation to parts of the brain at a greater depth and breadth compared to other focal TMS devices.
The system obtained the FDA clearance for the treatment of treatment-resistant major depressive disorder (MDD) in 2013.
FDA Division of Neurological and Physical Medicine Devices director Carlos Peña said: “Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches.
“With today’s marketing authorisation, patients with OCD who have not responded to traditional treatments now have another option.”
The FDA approval of BrainsWay Deep TMS device is based on data obtained during a randomised, multi-centre study conducted in a total of 100 patients at 11 medical centres across the US, Canada and Israel.
Of the 49 subjects treated with the Brainsway system for six weeks, 38% are said to have responded, with 30% decrease in Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
The results did not reveal any serious adverse reactions related to the device and the most frequent adverse reaction was observed to be headaches.
The device cannot be used by people who have metallic objects or implanted stimulator devices in or near the head, such as cochlear implants, deep brain and vagus nerve stimulators.