The Food and Drug Administration has approved humanitarian use of Medtronic's experimental deep brain stimulation device to treat severe obsessive-compulsive disorder.
It is the first approval for deep brain stimulation for a psychiatric condition. The technique is being studied for a variety of neurologic and psychiatric disorders, including treatment-refractory depression and Tourette syndrome.
Under the special Humanitarian Device Exemption (HDE) approval, Medtronic can market its device, Reclaim DBS Therapy, for obsessive-compulsive disorder (OCD). But the company will likely not pursue any marketing since it has not proved effectiveness, Mark Rise, Ph.D., a distinguished scientist in Medtronic's neuromodulation division, said in an interview. Also, under FDA rules, Medtronic can recover only the cost of research, development, fabrication, and distribution for Reclaim.
Medtronic will not pursue further development of Reclaim for OCD and is not sponsoring any studies in that condition. Instead, it will pursue the indication of treatment-resistant depression for the device, Dr. Rise said.
To gain HDE approval, a device must be intended to treat or diagnose a condition affecting fewer than 4,000 people per year in the United States. (Reclaim for OCD is currently intended to treat severe OCD patients for whom medication and psychotherapy is not working.) Also, a manufacturer has only to “demonstrate the safety and probable benefit” for a device to receive approval.
“Deep brain stimulation using the Reclaim system may provide some relief to certain patients with severe obsessive-compulsive disorder who have not responded to conventional therapy,” said Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health. It is not a cure, however. “Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment in functioning.
The agency approved Reclaim after reviewing data on 26 patients with treatment-resistant OCD. The most recent update of data on those patients was presented at the American Association of Neurological Surgeons annual meeting in April 2008.
According to the FDA, on average, patients had a 40% reduction in symptoms after 12 months of therapy.