Therapy System for Treating Major Depressive Disorder Receives FDA Clearance

MagVenture's MagVita TMS Therapy System® receives FDA clearance to be marketed as a medical device for the delivery of repetitive Transcranial Magnetic Stimulation (TMS) as a treatment for Major Depressive Disorder

Aug 28, 2015, 07:00 ET from MagVenture

LOS ANGELES, FARUM, Denmark and ATLANTA, August 28, 2015 /PRNewswire/ --

On July 31, 2015 the US Food and Drug Administration (FDA) cleared the MagVita TMS Therapy system for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. TMS is a non-invasive technique for stimulating neural tissue in the part of the brain implicated in patients suffering from Major Depressive Disorder. The procedure has been proven safe and effective and MagVenture is the fourth company since 2008 to receive clearance to market devices for the emerging brain stimulation technique.

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Benefits of the MagVenture MagVita TMS Therapy:

• Low operating costs: no per-use fees or costly disposable components.

• Safety and efficacy rates that are equivalent to other FDA cleared rTMS devices, including a simple design and workflow for optimal ease of use.

"MagVenture Inc. is very excited to begin offering the MagVita TMS Therapy system in the US. It was the first TMS system to be CE cleared in the EU (in 2011). The increased competitiveness in the market place will, ideally, drive down the cost of therapy and make the treatment modality an option for large numbers of depressed patients who were previously not able to receive TMS therapy due to the high cost," says MagVenture Inc. VP of Sales, Kerry Rome.

John O'Reardon, MD, Professor of Psychiatry at Rowan University: "I am very pleased to hear of the clearance by the FDA of the MagVenture device for the treatment of Major Depression. The MagVenture device is the latest TMS device to be cleared by the FDA and 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."

MagVenture Inc. has been the sales and support organization in the USA since 2010 (for neurodiagnostic and research applications of the technology) with offices in Georgia and California. The MagVita system and other MagPro® devices are produced by MagVenture's sister company Tonica in Denmark.

MagVenture is a medical device company, based in Denmark, and established in 2007. MagVenture specializes in non-invasive magnetic stimulation systems for depression treatment as well as research within neurophysiology, neurology, cognitive neuroscience, rehabilitation, and psychiatry.

MagVenture's product line of magnetic stimulators is sold under the brand name MagPro. The company sells its products through subsidiaries in the US as well as Germany, and through a network of distributors in Europe, Asia, Middle East, and the Americas.

Further information:  

Kerry Rome, Vice President Sales, MagVenture Inc., USA
+1-310-213-2697 /

MagVenture, Inc 
303 Perimeter Center North, Suite 300 / Atlanta GA 30346 
888-MAGPRO-4 /  

MagVenture A/S 
Lucernemarken 15 / 3520 Farum, Denmark 
+45-4499-8444 /

SOURCE MagVenture