Brainsway device approved for patients not responding to other treatments Patients with obsessive-compulsive disorder (OCD) whose symptoms persist despite standard therapy may be treated with a transcranial magnetic stimulation (TMS) device made by Israeli firm Brainsway, the FDA said Friday. "With today's marketing authorization, patients with OCD who have not responded to traditional treatments now have another option," an FDA official said in a statement. TMS devices have already been approved for treating depression and certain forms of migraine. Friday's decision -- technically, to permit marketing under the FDA's "de novo premarket review" pathway -- was based largely on a randomized, sham-controlled trial in 100 patients. Responder rates were 38% with active treatment versus 11% with the inactive sham, the agency said. No serious adverse effects were seen, and TMS therapy in the past has been generally benign. Headache was the most common adverse effect seen in the Brainsway studies, but rates were nearly equal with active versus sham treatment (38% versus 35%, respectively). For obvious reasons, the device should not be used on patients with metallic objects in or near the head. It emits loud noise and therefore patients should wear ear protection during treatment. Extra caution should be used in patients with a history of seizures. Source
