Medtronic ReclaimTM DBS Therapy for OCD

In February 2009, the Food and Drug Administration (FDA) gave approval of a Humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Medtronic Reclaim Therapy to Medtronic, Inc. Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions affecting fewer than 4,000 patients per year. In granting HDE approval for a humanitarian use device, the FDA focuses primarily on the safety of the device, rather than how well it helps. Although there is evidence that suggests the use of the Reclaim Therapy probably helps patients symptoms, the FDAs HDE approval indicates that the helpfulness of this therapy has not been proven. This is NOT a research study. Because of the type of approval given by the FDA, each Institution's IRB will need to review/approve. Therapy Indication The Medtronic Reclaim DBS Therapy is indicated for (meant to be used for) bilateral stimulation of the anterior limb of the internal capsule (a specific location in the brain) used along with patients medications and as an alternative to anterior capsulotomy (a different type of brain surgery that is not reversible) for treatment of chronic, severe, treatment-resistant OCD in adult patients who have failed at least three selective serotonin reuptake inhibitor (SSRI) medications.