Medtronic’s brain device receives FDA approval for severe anxiety disorder

Medtronic Inc’s implantable deep brain stimulator, Reclaim DBS Therapy, has received the FDA approval for facilitating the treatment process in severe cases of obsessive-compulsive disorder (OCD), in which drug and psychotherapy have been futile.

Medtronic said the device, to be made available by mid-2009, received FDA clearance on Thursday under the agency’s human device exemption policy under which, the device - already used for treatment of Parkinson’s disease, tremors and dystonia - could be used in fewer than 4,000 people yearly suffering from the anxiety disorder OCD.

The battery-powered Reclaim DBS Therapy device is lodged either near the patient’s collar bone or the abdomen, and its wire is attached to electrodes positioned in the brain. With the use of a small generator, pulsations of electricity are sent to both sides of the brain in an attempt to stimulate the brain.

FDA said that its decision of approving the device was based on its comprehensive analysis of its use in the case of 26 OCD patients, who indicated a 40 percent average drop of in the disorder symptoms after one year.

In a statement, Daniel Schultz, head of FDA’s Center for Devices and Radiological Health, said Reclaim DBS Therapy device “may provide some relief to certain patients with severe OCD who have not responded to conventional therapy; however, Reclaim is not a cure for OCD.”

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