February 22, 2009

FDA Approves OCD Treatment Device

Medtronic Inc.'s implantable deep brain stimulator has been approved by U.S. health officials to help treat patients with severe obsessive-compulsive disorders.

Thursday, the Reclaim DBS Therapy device's new use was cleared under the U.S. Food and Drug Administration's humanitarian device exemption policy.  The company said that the treatment is already used for Parkinson's disease, tremors and dystonia.

The humanitarian device exemption policy enables the development of medical devices intended to treat or diagnose a disease or condition of affecting fewer than 4,000 people per year in the United States.  In order to receive an approval, a company must demonstrate the safety and probable benefit of the device.

It "may provide some relief to certain patients with severe obsessive compulsive disorder who have not responded to conventional therapy," Daniel Schultz, head of the FDA's Center for Devices and Radiological Health, said in a statement.

"However, Reclaim is not a cure for OCD. Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment in functioning and continue to require medications," Schultz said.

The decision by the FDA was found after reviewing data on 26 patients with the condition who on average showed a 40 percent reduction of symptoms after a year of using the device.

The device is battery-powered and implanted either near the collar bone or the abdomen, and then connected by a wire to electrodes placed in the brain, according to the FDA.  There is a smaller generator that sends pulses of electricity to stimulate both sides of the brain.

OCD is an anxiety disorder that causes patients to have constant upsetting thoughts and then do an action repeatedly as an attempt to dispel them.

Common obsessive thoughts can include the fear of germs, or worry of being hurt.  Compulsive actions might include frequent cleaning, hand-washing, counting or checking, the FDA said.

Michael Kaplan, Medtronic spokesman, said the treatment should be available for hospitals to use on the OCD patients in mid-2009 and will cost about $60,000, including device and hospital costs.

He added that health insurers will decide whether to pay for the treatment based on a case-by-case basis.


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