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news.St. Jude Medical has received an investigational device exemption from the FDA to begin enrollment in a controlled, multi-site, blinded, clinical study of deep brain stimulation for major depressive disorder, a severe form of depression.
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The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) study will evaluate the safety and effectiveness of deep brain stimulation in patients with depression for whom currently-available treatments are not effective.
Chris Chavez, president of St. Jude Medical’s ANS division, said: “We are hopeful that this trial will lead to the successful development of a sustainable therapy for those patients who have exhausted other treatment options.”