The U.S. Food and Drug Administration (FDA) has approved Medtronic’s deep brain stimulator designed to help treat patients that suffer from severe obsessive-compulsive disorder, or OCD.
OCD is estimated to affect one in 50 adults in the United States. Medtronic said the Reclaim DBS will likely only be appropriate for use in less than 4,000 patients.
The device, Reclaim DBS therapy, a pacemaker-like device attached to four electrodes that deliver electrical jolts to brain areas that regulate mood and anxiety, was approved on Thursday under the FDA’s humanitarian device exemption policy, the agency said.
Under such approvals, Medtronic is required to show the device was safe and offered “probable benefits.”
The Reclaim DBS therapy will be available to a small group of OCD patients that have not responded to other treatment options.