The US Food and Drug Administration (FDA) granted 510K clearance to market a new transcranial magnetic stimulation (TMS) device, the MagVita TMS Therapy system from MagVenture, for treatment of adults with drug-resistant major depressive disorder, according to a company news release.
TMS has been shown to be safe and effective for patients with major depressive disorder who do not respond adequately to antidepressant medication.
The company says the benefits of the new system include a simple design and workflow for optimal ease of use, low operating costs, no per use fees or costly disposable components, and safety and efficacy rates that match other FDA-approved TMS devices.
The system includes the TMS device, treatment chair, coils, isolation transformer, vacuum pump, and pillow.
The MagVita TMS Therapy system can run many protocols successively (up to 20.000 pulses), the company notes in its release. The treatment protocol consists of an initial session to determine a patient's individual stimulation level and five treatment sessions per week during a period of 6 weeks.
The system was cleared in the European Union in 2011.
"MagVenture's FDA approval is good news for patients and the entire brain stimulation community," Mark George, MD, director of the Brain Stimulation Laboratory, Medical University of South Carolina in Charleston, said in a news release. "One of my earliest TMS machines was made by Dantec, the precursor company for MagVenture. I still have this machine and use it for teaching. MagVenture won the contract for an ongoing Veterans Affairs...Cooperative Study trial of TMS in depressed veterans. We have thus been working with them closely in this trial. We also have their system at [the Medical University of South Carolina] for use in other research studies."
John O'Reardon, MD, professor of psychiatry, Rowan University, Glassboro, New Jersey, added in the new release that this latest TMS device to be cleared by the FDA "offers a treatment alternative for psychiatrists who are managing cases of treatment resistant depression. I have personally worked with the MagVenture MagPro device for 7 years now and find its ease of use and reliability very attractive."
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Cite this: FDA Clears New Brain Stimulation System for Depression - Medscape - Aug 31, 2015.