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New NeuroStar Transcranial Magnetic Stimulation Therapy System for Depression Cleared by FDA

April 17th, 2017 Medgadget Editors Neurology, Psychiatry

Neuronetics, a firm based in Malvern, Pennsylvania, won FDA approval for its latest NeuroStar transcranial magnetic stimulation therapy system. Approved in the U.S. for treating depression in patients who have tried at least one antidepressant drug, the new system has the major benefit of offering the same therapy during shorter sessions. Although session duration is decided on by the physician, many sessions can be complete within twenty minutes.

This technology is not to be confused with electroconvulsive therapy that sends electric current through the brain, instead relying on focused magnetic fields that don’t seem to cause any serious side effects.

The system features laser positioning and a sensor that feels the contact pressure of the magnetic field generator against the head, helping to get therapy sessions started quickly and with little discomfort.

Some details from Neuronetics:

The majority of people who benefited from treatment with NeuroStar experienced clinically meaningful, long-lasting improvement; NeuroStar had proven durability over 12 months in an open-label clinical trial. Additionally, over the past year, there has been approximately a 20 percent increase in the number of NeuroStar systems across the country — further increasing patient access to this transformative treatment.

NeuroStar is indicated for the treatment of MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. In an NIMH-funded, independent, randomized controlled trial, patients treated with TMS using a clinical-trial version of the NeuroStar TMS System were four times more likely to achieve remission compared to patients receiving sham treatment (P = 0.0173; odds ratio = 4.05).

The most common side effect is pain or discomfort at or near the treatment site, which usually resolves within one week. It is contraindicated in people with non-removable conductive metal in or near the head. Long term durability of effect has not been established in a randomized controlled trial.

Flashbacks: The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack, M.D…; Neuronetics’ NeuroStar TMS for Major Depressive Disorder Cleared in Europe…; Neuronetics TMS Depression Therapy Gets FDA OK…

Via: Neuronetics…

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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