Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. ...Read More
This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
22 medical centers in the USA, Canada, Europe and Israel
16 September, 2009
A multicenter clinical trial for the assessment of the efficacy and safety of Brainsway® Deep TMS in subjects suffering from major depression disorder (MDD) took place in 22 medical centers in the USA, Canada, Europe and Israel.
The purpose of the study was to evaluate the efficacy and safety of Brainsway Deep TMS, in subjects suffering from Major Depressive Disorder who have been unsuccessfully treated with antidepressant medication.
The study, which took place over 16-weeks, is a Double-Blind Placebo-Controlled study which enrolled over 230 subjects. The results showed a profound decline in HDRS-21 and significant remission (32.6%) and response (38.4%) rates at the primary endpoint of the study. Brainsway treatment was proved to be safe, as the treatment was well tolerated by the majority of the study subjects.
Following this study, the FDA* granted Brainsway a wide indication for the treatment of Depression patients who did not benefit from any number of previous medication treatments.
* FDA 510(k) No. K122288