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Medtronic Inc’s Reclaim DBS therapy was approved under a humanitarian device exemption, which means that the system will be used on a relatively small number of adults (no more than 4000 and probably considerably fewer) with recalcitrant OCD.
The DBS device offers an adjustable, reversible, and nondrug therapy. This surgically implanted device- similar to a pacemaker- delivers carefully controlled electrical pulses to precisely targeted areas of the brain.
Only one other medical device has been approved for treatment of a psychiatric condition: the vagus nerve stimulation (VNS) implantation device made by Cyberonics. In 1997, the FDA approved the use of VNS as an adjunctive therapy for partialonset epilepsy; in 2005, its use in treatment-resistant depression was also approved. But Benjamin D. Greenberg, MD, PhD, told Psychiatric Times that VNS has been somewhat controversial, and insurance reimbursement remains an issue. Greenberg, who is associate professor of psychiatry at Brown University Medical School in Providence, RI, noted, however, that VNS does not involve brain surgery, as DBS does. Thus, the potential adverse effects from DBS, while relatively rare, can be more serious.
Greenberg is associated with Butler Hospital in Providence, where part of the Medtronic pilot study that paved the way for FDA approval took place. Greenberg was the lead US investigator in a pilot study of 26 patients; that study was funded by Medtronic and the National Alliance for Research on Schizophrenia and Depression. Dr Greenberg has received honoraria from Medtronic for consulting and speaking in addition to research funding.
Medtronic’s DBS device has been used in this country since the early part of this decade. But only a few academic medical centers are qualified to combine the type of psychiatry and neurosurgery that results in successful outcomes, which includes minimizing adverse reactions, according to Greenberg. Greenberg estimated that OCD is resistant to conventional treatment approaches in fewer than 5% of patients.
“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 Daniel Schultz, MD, director of the FDA Center for Devices and Radiological Health.
“I hope use of this therapy unfolds cautiously,” stated Greenberg. “Specialized psychiatric neurosurgery teams need to be created for the best results. Such teams need to be really good at assessing which individuals are the best candidates; that is, that OCD is the primary diagnosis, and that the illness has remained severe despite aggressive uses of conventional treatments. I particularly worry that desperate people who may not be good candidates might, with the best of therapeutic intentions, receive an implant.”
Kristin Lambrecht, emerging business development manager of Medtronic, emphasized that psychiatrists must be committed not only to carefully selecting patients but also to long-term treatment of those patients. “The device needs to be reviewed periodically, and the battery needs to be checked,” she explained.
FDA approval based on the humanitarian device exemption requires that a hospital has the capability to do the surgery and informed patient consent is obtained. Greenberg said that the Butler Hospital and 3 other academic centers (Massachusetts General; the Cleveland Clinic; and the University of Florida, Gainesville) are now receiving funding from the NIH to do a controlled study of DBS using a brain electrode that will more specifically target the brain region of interest.