This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in a person’s mood, energy, and ability to function. Different from the normal ups and downs that everyone goes through, the symptoms of bipolar disorder are severe. They can result in damaged relationships, poor job or school performance, and even suicide. About 5.7 million American adults or about 2.6 percent of the population aged 18 and older in any given year, have bipolar disorder.
Bipolar disorder typically develops in late adolescence or early adulthood. However, some people have their first symptoms during childhood, and some develop them late in life. It
is often not recognized as an illness, and people may suffer for years before it is properly diagnosed and treated. Like diabetes or heart disease, bipolar disorder is a long-term illness that must be carefully managed throughout a person’s life. As bipolar disorder is associated with pathologies within the reward system, repeated activation of prefrontal regions and the deeper reward-related network innervated by the prefrontal cortex by Deep TMS, may allow effective treatment of this chronic disease.
Conventional treatments include various combinations of antidepressants and mood-stabilizers such as lithium. However, there is no consensus and very limited clinical data regarding both the effectiveness of these treatments and the possibility that antidepressant medication might exacerbate the intensity and frequency of manic episodes in bipolar patients. Treatment with conventional antidepressant medication may trigger a manic attack or accelerate the bipolar cycle1.
ECT is administered as a treatment in cases of treatment-resistant manic or depressive episodes, or in cases where medication produces severe side effects.
BrainsWay’s* treatment offers an effective*, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation (TMS) for treating bipolar disorder. The treatment performs magnetic stimulation of brain structures and networks related to bipolar disorder, and brings significant improvement to patients.
It is an outpatient procedure and does not require hospitalization or anesthesia, is generally well tolerated and entails minimal systemic side effects*.
The final report of a previous clinical trial conducted by BrainsWay states that the treatment was well-tolerated by all subjects, and a clinical response was achieved in 70% of the subjects (of whom a vast majority displayed significant improvement) as compared with
previous treatment with anti-depressants that were given to the subjects.
BrainsWay Deep TMS therapy is approved by the CE* and by ANIVISA for treating Bipolar Disorder.
 Antai-Otong D. Treatment considerations for patients experiencing rapid-cycling bipolar disorder.Perspect Psychiatr Care. 2006 Feb;42(1):55-8
* Click here for references
IMPORTANT: BrainsWay is at different stages of regulatory approval for different indications in different countries. While the status of our regulatory approvals is generally updated on this website, in order to verify whether BrainsWay is currently approved in your area for the treatment of bipolar disorder, please contact us at firstname.lastname@example.org
You are viewing a page that is not intended for persons in the United States, and includes information about treatment applications that HAVE NOT BEEN CLEARED by the FDA for safety and efficacy.