FDA approves expansion of St. Jude Medical's BROADEN deep brain stimulation study for depression

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, 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.

“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.”

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 (DBS) 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."

The BROADEN study is a controlled, blinded study that utilizes the St. Jude Medical Libra^™ deep brain stimulation system. Prior to the expansion, this study was conducted at only three centers located in Chicago, New York City and Dallas. Participants must be classified as having treatment-resistant depression and must have failed multiple treatments to be a candidate for the study.

"We are committed to leading this important research in hopes of finding a solution for people who currently don't have a treatment option," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "By expanding the BROADEN study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder."

The BROADEN study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). St. Jude Medical will request approval to expand the study to a total of 231 patients at a later date. To locate participating centers, please visit www.BROADENstudy.com or call toll-free 866-787-4332.

To be eligible for this study, participants must:

• Have been diagnosed with major depressive disorder (MDD)
• Be between 21 and 70 years old
• Have had first depressive episode before age 45
• Have tried at least four treatments in their current episode (for example, different medications, different combinations of medications, and/or electroconvulsive therapy (ECT))

The BROADEN study builds upon an earlier St. Jude Medical pilot study which reported that at six months, 62 percent of the patients experienced at least a 40-percent decrease in symptoms of depression as measured by a standardized test called the Hamilton Rating Scale for Depression. Of these patients, 92 percent maintained this improvement at their last follow-up visit (typically at one year).

A non-pharmacological therapy, deep brain stimulation uses mild pulses of current from an implanted device to stimulate the brain. DBS leads are surgically positioned in the brain at a specific target and connected with a neurostimulator that is typically placed under the skin near the collarbone.

In the U.S., more than 21 million adults suffer from some kind of depressive disorder, according to the National Institute of Mental Health (NIMH). Of these, approximately 4 million live with severe depression that does not respond to medications, psychotherapy and, in certain cases, ECT.