FDA Clears TMS Device for Resistant Depression

Caroline Cassels

January 09, 2013

The US Food and Drug Administration (FDA) today cleared the transcranial magnetic stimulation (TMS) system manufactured by Brainsway Ltd for treatment-resistant major depression.

According to a press release posted on the company's Web site, the FDA approval for this indication is "generally broader than the definition given by the company's TMS device rival," presumably referring to the Neuronetics Neuro-Star system, which was cleared by the FDA for the same indication in 2008.

In April 2012, and reported by Medscape Medical News at that time, the company released top-line results from a double-blind, multicenter controlled trial showing that its TMS system was safe and effective in this patient population.

After 5 weeks of treatment, 30.4% of patients in the active treatment group achieved remission from depression, which was defined as a Hamilton Depression Rating Scale (HDRS-21) score of less than 10. In comparison, 14.5% of the sham treatment control group achieved remission (P = .0148), according to information released by Brainsway Ltd, developers of the device used in the study.

Further, the company reported that there was a significant response to treatment, defined as a greater than 50% decrease from baseline HDRS-21 scores, in 36.7% of patients in the active treatment group vs 20.5% in the control group (P = .0148).

The release also noted that the FDA clearance of its TMS system marks "an important breakthrough for the company and opens an important US market."