February 19, 2009 / 5:41 PM / 11 years ago

UPDATE 2-US FDA approves Medtronic brain device for OCD

 * FDA grants approval as a human device exemption
 * Results may vary, certain patients may benefit -FDA
 * Therapy to cost about $60,000 company says  (Adds company comments, other details)
 By Susan Heavey
 WASHINGTON, Feb 19 (Reuters) - U.S. health officials have approved Medtronic Inc’s (MDT.N) implantable deep brain stimulator to help treat patients with severe obsessive-compulsive disorder.
 The Reclaim DBS Therapy device’s new use was cleared on Thursday under the U.S. Food and Drug Administration’s human device exemption policy. The treatment is already used for Parkinson’s disease, tremors and dystonia, a movement disorder, the company said.
 Human device exemptions enable the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people per year in the United States. To receive 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.
 FDA said it based its decision after reviewing data on 26 patients with the condition who on average showed a 40 percent reduction of symptoms after one year of using the device.
 Medtronic’s battery-powered device is implanted either near the collar bone or the abdomen and is connected by a wire to electrodes placed in the brain, according to the FDA. A small generator sends pulses of electricity to stimulate both sides of the brain.
 OCD is a type of anxiety disorder that causes patients to have constant upsetting thoughts and then do an action repeatedly in an attempt to dispel them.
 Often such obsessive thoughts include the fear of germs or worries about being hurt. Compulsive actions can include frequent cleaning, hand-washing, counting or checking, the FDA said.
 Medtronic spokesman Michael Kaplan said the treatment should be available for hospitals to use with OCD patients in mid-2009 and would cost about $60,000, including device and hospital costs.
 Health insurers would decide whether to pay for the treatment on a case-by-case basis, he added.  (Editing by Tim Dobbyn and Matthew Lewis)  

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