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Patients suffering from severe obsessive-compulsive disorder that has not responded to medication and psychotherapy appropriately have now the chance to improve their condition thanks to a new device approved by the Food and Drug Administration on Thursday.
The device, called Reclaim Deep Brain Stimulator, is made by Medtronic, the leading player in the so-called neuromodulation market. Although patients receiving the device will continue to have some mild to moderate impairment, it is seen as a rescue for hundreds of people whose lives have been somewhat destroyed by the disorder.
OCD is an anxiety disorder characterized by recurring negative thoughts or uncontrollable desire to perform repetitive behaviors such as hand washing or cleaning.
The FDA based its approval on a clinical study on 26 patients at three US medical centers. Some of them suffered serious side effects but they all got resolved without lasting damage. The procedure carries a risk of life-threatening cerebral hemorrhage and brain infection.
Medtronic has been pursuing research of DBS for psychiatric disorders for more than a decade in collaboration with physicians from many leading institutions. The first DBS implant for treatment-resistant depression was performed in a physician-sponsored study supported by Medtronic at Butler Hospital in Providence, R.I. in 2003.
Now Medtronic wants to test deep brain stimulation in patients suffering from severe depression competing in this field with St. Jude Medical Inc. ( STJ), which also has a deep-brain stimulation system and announced the first implant in its pivotal study in June last year. The two companies are big competitors in the field of implanted heart rhythm devices.
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