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St. Jude Medical Awarded U.S. Patent for Neurostimulation Therapy for Depression
Monday, April 21, 2008
Brodmann Area 25 Study Moves Forward With Enrollment of First Patient
St. Paul, MN -- St. Jude Medical, Inc. (NYSE: STJ) today 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.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.
About the ANS Division of St. Jude Medical
The ANS Division (Advanced Neuromodulation Systems) became a part of St. Jude Medical in 2005. The ANS Division is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders (www.ans-medical.com).
About Alexian Brothers Behavioral Health Hospital
Alexian Brothers Behavioral Health Hospital, located in Hoffman Estates, Ill., offers comprehensive behavioral health services, from prevention and early intervention to treatment and aftercare. Their mission is to help individuals of all ages learn practical ways to manage mental health and substance abuse problems. Alexian Brothers Behavioral Health Hospital has earned the Joint Commission's Gold Seal of Approval for Disease-Specific Certification in Depression, Chemical Dependency, Eating Disorders, and Self-Injury. Alexian Brothers Behavioral Hospital is part of the Alexian Brothers Health Hospital Network, a diversified Catholic healthcare system based in Arlington Heights, Ill., and comprised of four hospitals which serve the nearly two million residents of Chicago's northwest suburbs (www.alexianbrothershealth.org).
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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