FDA approval for the first implantable deep brain stimulator for severe OCD
The FDA has approved the first implantable deep brain stimulator used to treat severe OCD (obsessive compulsive disorder). According to the FDA, data collected from the 26 patients that have used the device thus far indicates a 40% reduction in symptoms overall. David Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, warned that the device is not a cure for the disorder. “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,” he said.
The device, called reclaim, can be implanted near the collar bone or in the abdomen and is connected to four electrodes in the brain. Reclaim is expected to be available for consumer’s midyear 2009. The following is an excerpt of an article from Medpage Today that discusses the device further:
The approval was made following a review of data from 26 patients who were treated with the device. After 12 months of therapy, there was an average reduction in symptoms of 40%, according to the FDA.
Most adverse events — including mood changes and anxiety — were diminished after adjusting the amount of electricity delivered.
The FDA said the device should not be used in patients who require electroconvulsive shock therapy or in those who will undergo magnetic resonance imaging or diathermy.
Medtronic said that patients are being enrolled into a multicenter, randomized controlled trial to evaluate the effectiveness of Reclaim for treatment-resistant depression.