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news.Medtronic, a medical technology company, has received approval from the FDA for a humanitarian device exemption for its Reclaim deep brain stimulation therapy for chronic, severe obsessive-compulsive disorder.
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The company also announced the first enrollment in its multi-center, randomized clinical trial of deep brain stimulation (DBS) for treatment-resistant depression.
Medtronic is proceeding with the FDA investigational device exemption approval for five centers to enroll patients in the clinical trial of DBS for treatment-resistant depression throughout the US, including the Cleveland Clinic, which was the first to enroll a patient in the trial.
According to the company, Reclaim DBS is the first medical device to receive the FDA’s approval for the treatment of obsessive-compulsive disorder (OCD) and is also the first psychiatric indication to be approved for DBS.
Ali Rezai, neurosurgeon at Cleveland Clinic and investigator in early studies of DBS for OCD, said: For patients with OCD, DBS therapy represents an alternative therapeutic approach, which may be an option for patients who did not experience a benefit from more traditional treatments. The clinical trial of DBS in treatment-resistant depression is an important step in understanding this therapeutic approach for patients with severe depression.