The device is Medtronic's Reclaim deep-brain stimulation (DBS) device. It will be used as a last-ditch therapy to treat patients who have failed multiple different therapies for OCD.
"This is essentially like a pacemaker for the brain," Hackensack University Medical Center neurosurgeon Hooman Azmi, MD, tells WebMD. "There is an electrode implanted in brain and wires run under the skin and attached to a generator that is also implanted in the body. And doctors have control where they can decrease or increase the electrical stimulation."
The FDA's "humanitarian device exemption" permits use of the device on only the most severely ill people with OCD. Fewer than 4,000 patients have such drastic, treatment-resistant OCD.
The decision is based on a clinical study of 26 patients at three U.S. medical centers.
"DBS is a promising treatment for a subset of patients with OCD who have remained very ill and debilitated despite aggressive use of medications and cognitive behavioral therapy," study leader Benjamin D. Greenberg, MD, PhD, said in a news release.
Because implantation of the device carries serious risks, the treatment isn't for most OCD sufferers, says Azmi, who is familiar with the details of the clinical study but was not involved in it.
"The patients they looked at are really the most ill of the ill. They have so much disability from OCD that they really have lost all of what we would consider a life," Azmi says. "They have become unable to work. Some cannot hold on to any relationships; some cannot even leave the house."
Patients in the Greenberg study showed remarkable improvement.
"Some could go back to work, some could again have relationships and participate in life," Azmi says. "And more important, some of the patients could participate in behavior therapy as well, and that likely had a role in their overall progress."
There were also serious risks. Eleven of the 26 patients suffered a total of 23 serious adverse events. Fortunately, all resolved without lasting damage. But the procedure carries a risk of life-threatening cerebral hemorrhage and brain infection.
The treatment requires an interdisciplinary team of experts for selecting the right patients, implanting the device, adjusting the electrical stimulation to the brain, and managing patients over the long term.
The Reclaim DBS device is similar to devices used to treat Parkinson's disease and other movement disorders. However, because it stimulates a different part of the brain, Medtronic developed special electrodes for use in OCD.
The device is now being tested in patients with extremely severe depression in a U.S. trial.