St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for Depression

St. Jude Medical, Inc. STJ today announced that the U.S. Food and Drug Administration (FDA) has granted approval for expansion of its BROADEN™ (BROdmann Area 25 DEep brain Neurostimulation) study for depression. This expansion will allow a maximum of 20 sites across the U.S. to enroll up to 125 patients. The BROADEN study is investigating whether or not stimulating an area of the brain known as Brodmann Area 25 (BA25) with a deep brain stimulation system is a safe and effective method for treating severe depression. “Deep brain stimulation could potentially change the way that we look at treating patients suffering with severe depression,” said Mark George, M.D., distinguished professor of psychiatry, radiology and neurology at the Medical University of South Carolina. “Treatments such as medications, psychotherapy and electroconvulsive therapy often fail to work for these very difficult-to-treat patients, so we are hopeful this research will provide us with a new approach to treating this debilitating condition.”