FDA Approves Implant Device for OCD Treatment

Approximately 1 in 50 U.S. adults suffer from obsessive-compulsive disorder (OCD) which is the fourth most common mental disorder. OCD is characterized by unrelenting repetitive thoughts that compel a person to behave compulsively and perform mental acts. These behaviors and acts are based upon following rigid rules to prevent an imagined and feared consequence, although they are not connected to the imagined and feared event. Obsessive thoughts may include a fear of germs or personal injury, while compulsive actions may include frequent cleaning, hand washing, counting, or checking.

In severe cases, a patient’s ability to function in everyday activities is effected, causing a decline in the degree of the individual’s well being. In addition, the patient is often painfully aware of the irrationality of their disorder as it can take several hours daily to carry out compulsive acts.

Recently, the U.S. Food and Drug Administration (FDA) approved the first implant device to treat severe OCD. According to the government agency, the Reclaim DBS Therapy device distributes electrical pulses deep within the brain to suppress the symptoms associated with severe OCD. Medtronic Incorporated manufactures this device intended for use in the treatment of patients who are not responding well to medication and psychotherapy.

The use of the Reclaim system was cleared for use under the FDA’s human device exemption policy. According to the FDA, the treatment is already used for Parkinson's disease, tremors and dystonia (a movement disorder). Human device exemptions allow for the development of medical devices intended to treat or diagnose a disease or condition in fewer than 4,000 people per year in the U.S. The safety and probable benefit of the device must be demonstrated prior to receiving FDA approval.

The FDA’s favorable decision came after examining data on 26 OCD patients who experienced a 40 percent reduction of symptoms, on average, after one year of using the device. Although all of the patients reported adverse events, most events ended following an adjustment in the amount of electrical stimulation.

A small electrical generator is used by the Reclaim system to produce electrical stimulation to block abnormal nerve signals within the brain. The battery-powered device is implanted near the collarbone or abdomen and is then connected to four implanted electrodes in the brain. Either two device systems or one device with two lead outputs may be implanted to achieve stimulation for both sides of the brain.

Daniel Schultz, head of the FDA's Center for Devices and Radiological Health, said in a statement that the device “may provide some relief to certain patients with severe obsessive compulsive disorder who have not responded to conventional therapy.” He also warned, “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.” Certain patients, such as those who require electroconvulsive shock therapy and those who will undergo magnetic resonance imaging (MRI) or deep tissue heat treatment (cardiomyopathy) are not candidates for implantation of the Reclaim device.

The treatment should be available for use in hospital patients with OCD by mid-2009 with an expected cost of about $60,000, including the device and hospitalization, according to Medtronic spokesman Michael Kaplan. He said that health insurers would decide upon coverage for the treatment on a case-by-case basis.