St. Jude Medical awarded U.S. patent for neurostimulation therapy for depression

Apr 21 2008

St. Jude Medical, Inc. has announced it has been awarded a patent from the U.S. Patent and Trademark Office for treating depression using neurostimulation therapy in an area of the brain known as Brodmann Area 25.

Brodmann Area 25 is a structure within the subcollosal gyrus region of the brain. It is the focus of the St. Jude Medical BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) study, which is evaluating whether deep brain stimulation (DBS) therapy can help people who suffer from major depressive disorder, a severe form of depression. This study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), which was announced in February 2008.

“This patent is a cornerstone in developing our approach to deep brain stimulation for depression, which is the leading cause of disability in the U.S. among illnesses,” said Chris Chavez, president of St. Jude Medical’s ANS Division. “The BROADEN study provides hope for a meaningful new therapy to the millions of patients still seeking treatment for their severe depression.”

On April 4, St. Jude Medical enrolled the first patient, a woman from Chicago, in the BROADEN study. The patient will be implanted with the Libra® Deep Brain Stimulation System, an investigational device, at Alexian Brothers Behavioral Health Hospital in Chicago.

“There is a tremendous need for research in the area of major depressive disorder, particularly among those who have exhausted other treatment options,” said Anthony D'Agostino, M.D., medical director of Alexian Brothers Behavioral Health Hospital and the principal investigator at the study site. “We hope that our participation in the study will add to the body of research previously conducted for patients suffering from depression and, if possible, shed some light on what type of patient is most likely to benefit.”

Co-investigators at Alexian Brothers Behavioral Health Hospital are psychiatrists Greg Teas, M.D., Mark Lerman, M.D. and neurosurgeon Konstantin Slavin, M.D.

The BROADEN study is a controlled, multi-site, blinded, clinical study of deep brain stimulation in the U.S. It will build upon the pioneering depression work conducted at the University of Toronto by a research team led by neurologist Helen S. Mayberg, M.D. (now with Emory University School of Medicine) and neurosurgeon Andres Lozano, M.D.

The Libra Deep Brain Stimulation System, which is being evaluated in this study, is designed to deliver mild pulses of current from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.

In the U.S., more than 21 million adults suffer from some kind of depressive disorder, according to the National Institute of Mental Health. Since only about 80 percent can be effectively treated with currently available therapies, approximately 4 million adult Americans live with depression that does not respond to medications, psychotherapy or electroconvulsive therapy. The World Health Organization estimates that depression affects about 121 million people worldwide.

For more information about this study, call toll-free 866-787-4332 or visit www.BROADENstudy.com.