Medtronic‘s Reclaim deep brain stimulation system has received a humanitarian device exemption (HDE) from the FDA for treatment of severe cases of obsessive-compulsive disorder (OCD). Such a ruling, without apparent hard data on efficacy of the treatment for OCD, shows that the FDA nevertheless believes the device will probably do more good than harm in a highly preselected group of patients.
From a Medtronic press release:
The company also announced the first enrollment in its multi-center, randomized clinical trial of DBS for treatment-resistant depression. Medtronic is proceeding with U.S. 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 U.S. FDA approval for the treatment of OCD and is also the first psychiatric indication to be approved for DBS. Medtronic plans to make Reclaim DBS Therapy for OCD available in the United States by mid-2009.
Study Results of DBS for OCD
Collaborative clinical research of DBS therapy using Medtronic devices began in 1998 with the first implant in Europe (the Catholic University of Leuven in Belgium). The research was also conducted at three U.S. medical centers (Butler Hospital in Providence, R.I., Cleveland Clinic, and University of Florida, Gainesville). These institutions studied DBS therapy in 26 patients with severe, treatment-resistant OCD and the data from the studies were consolidated and recently published in the journal, Molecular Psychiatry. The combined long-term results of those studies reveal clinically meaningful symptom reductions and functional improvement in about two-thirds of patients. In addition, a majority of the 26 patients moved from a severe OCD rating at the start of the study to a mild or moderate rating at various follow-ups after device implantation. The reductions in OCD symptoms were associated with marked functional improvements in psychological, social and occupational domains.
As the authors reported in the publication, a total of 23 serious adverse events were reported in 11 subjects (42 percent) of which 15 of the 23 events were associated with the surgical implant procedure, device, or therapy, all of which were resolved without sequelea. Adverse events such as changes in mood and anxiety were transient and most of them resolved with stimulation parameter changes. The studies show DBS for OCD may hold promise as a therapy when there is a dedicated interdisciplinary team that is expert in patient selection, implantation, stimulation and the long-term management of severely ill psychiatric patients.
Press release: Medtronic Receives FDA HDE Approval to Commercialize the First Deep Brain Stimulation (DBS) Therapy for a Psychiatric Indication in the United States
Product page: Reclaim™ DBS Therapy for Obsessive Compulsive Disorder