FDA Clears NeuroStar(R) TMS Therapy for the Treatment of ...( First and Only Non-systemic and N...),Health

First and Only Non-systemic and Non-invasive Treatment Cleared for Patients Who Have Not Benefited From Prior Antidepressant Treatment

MALVERN, Pa., Oct. 8 /PRNewswire/ -- Neuronetics, Inc., a privately-held medical device company and a leader in the field of neuromodulation, announced today that the U.S. Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system for the treatment of depression. NeuroStar TMS Therapy(R) is specifically indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. In clinical trials with NeuroStar TMS Therapy, these patients had been treated with a median of 4 medication treatment attempts, one of which achieved criteria for adequate dose and duration.

"Clinical neuroscience advances have greatly improved the diagnosis and treatment of depression, but much more is needed. These disorders lead the world in producing disability, and more than half of the millions being treated for clinical depression currently fail to achieve wellness," said John Greden, MD, Professor of Psychiatry & Clinical Neurosciences and Executive Director of the University of Michigan Comprehensive Depression Center. "Before now, few options have been available for them other than complex and often unproven combinations of medications. Now, with the FDA clearance of NeuroStar TMS Therapy, there is new hope."

The NeuroStar TMS Therapy system is the first and only TMS Therapy(R) device cleared by the FDA for the treatment of depression. TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused
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