FDA Clears a Second Device Treatment for Depression

FDA has cleared a neuromodulation treatment for depression. The NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy System, made by Neuronetics Inc., becomes the second medical device treatment OK'd to treat depression. It is indicated for treatment of major depressive disorder in adult patients who have not responded to drug treatment. It is the first noninvasive, non-systemic treatment.

October 9, 2008

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FDA Clears a Second Device Treatment for Depression

It works by delivering highly focused MRI-strength magnetic pulses to an area of the brain that is linked to depression. The pulses stimulate certain nerve cells. The therapy is a 40-minute outpatient procedure intended to be performed at a psychiatrist's office. It is administered daily for 4-6 weeks.The first device depression treatment, VNS Therapy from Cyberonics, did not live up to commercial expectations because CMS declined to reimburse for the procedure, which requires surgery to implant a device in the chest. Since there is no surgery involved with the Neurostar system, it's tough to predict what CMS will decide in terms of reimbursement -- or if the firm will even seek reimbursement. The procedure will only be offered at a few treatment centers around the country.

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