The Medtronic Reclaim Deep Brain Stimulation system uses a small electrical generator to create electrical stimulation that blocks abnormal nerve signals associated with obsessive compulsive disorder. The battery-powered device is implanted near the abdomen or collar bone and connects to four electrodes implanted in the brain through an insulated electric lead wire.

Patients may soon have access to a new treatment for obsessive compulsive disorder (OCD), thanks to an implantable device that delivers intermittent electrical therapy deep within the brain.

The link to Medtronic Reclaim Deep Brain Stimulation (DBS) system uses a small electrical generator, known as a pulse generator, to create electrical stimulation that blocks abnormal nerve signals. The battery-powered device, implanted near the abdomen or the collar bone, connects to four electrodes implanted in the brain through an insulated electric lead wire. Doctors can implant two devices to stimulate both sides of the brain, or one device with two lead outputs.

The Reclaim system received an FDA Humanitarian Device Exemption (HDE), which facilitates development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people per year in the United States. An HDE application is similar to a premarket approval (PMA), but it is exempt from the effectiveness requirements of a PMA. To receive HDE approval, a company must demonstrate the safety and probable benefit of the device.

Approval of the Reclaim system came after reviewing data from 26 patients with severe treatment-resistant OCD. On average, patients had a 40% reduction in their symptoms after 12 months of therapy. The system will provide relief, but it won’t cure OCD, says Daniel Schultz, director, Center for Devices and Radiological Health. Medtronic is proceeding with FDA Investigational Device Exemption (IDE) approval for five centers to enroll patients in the clinical trial of DBS for treatment-resistant depression throughout the United States, including the Cleveland Clinic, which was the first to enroll a patient in the trial.

Reclaim DBS is the first medical device to receive FDA approval for the treatment of OCD and is also the first psychiatric indication to be approved for DBS.