BrainsWay's Next Generation Stimulator For Treatment of MDD Cleared by FDA

BrainsWay announced that its new stimulator, to be integrated into BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) System for the treatment of major depressive disorder (MDD), received US Food and Drug Administration (FDA) 510(k) clearance.

The new stimulator was demonstrated at the American Psychiatric Association Annual Meeting in New York City.

The non-invasive stimulator provides enhanced features focused on increasing the ease of use for the physician, stimulating the brain region responsible for depression.

The treatment integrates enhanced energy utilization, a patient management system with the built-in depression treatment protocol and a user-friendly tool for accurate, rapid motor threshold detection, and will decrease set-up time and increase office efficiencies.

The FDA indication is based on a unique long-term 16-week, double-blind, placebo-controlled, multicenter study which enrolled more than 200 subjects.

The trial reported a decline in Hamilton Depression Rating Scale (HDRS-21) scores, as well as significant remission (32.6%) and response (38.4%) rates at primary endpoint after 4 weeks of acute treatment.

“BrainsWay’s new stimulator represents a very important product advancement that solidifies the company’s leading innovative positive within the US market,” Yaccov Michlin, chief executive officer, BrainsWay, said in a statement.

The treatment is an outpatient procedure that does not require hospitalization or anesthesia and entails no memory loss or systemic side effects.

The next-stimulation enhancer enhances the deep TMS and streamlines treatment for both physicians and patients.

The technology features BrianWay’s unique, patented H-Coil and is a clinically-effective therapeutic platform with expandable functionality. The proprietary H-Coil technology reaches deeper and greater surface areas of the brain than standard TMS treatments.

The coil is fitted into a helmet, which is secured to the patient’s head during treatment. The helmet generates brief magnetic fields at a similar amplitude to that in magnetic resonance imaging (MRI) systems. The magnetic fields briefly stimulate the targeted brain area and improve depressive symptoms.

The procedure requires daily sessions of 20 minutes throughout 4—6 weeks.

The treatment has been proven safe and effective and has no known systemic effects. The most common side effects are headaches and local discomfort, both often temporary and mild; additional side effects may include muscle twitching and jaw pain.

The treatment has FDA clearance for marketing and CE mark for MDD as well as CE mark for posttraumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, smoking cessation and more.

The technology is currently available in the US, Europe and South America.

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