Healthcare Industry News: Advanced Neuromodulation Systems
News Release - February 7, 2008
St. Jude Medical Announces Clinical Study of Deep Brain Stimulation for Depression
Research to focus on the Brodmann Area 25 region of the brainST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (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.
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. The study will build upon the pioneering depression work of a research team from the University of Toronto, led by neurologist Helen S. Mayberg, M.D. (now with Emory University School of Medicine), and neurosurgeon Andres Lozano, M.D.
“Major depressive disorder is severely disabling,” said Dr. Lozano. “Currently, there are no widely-accepted treatment options for patients with this condition once multiple medications, psychotherapy and electroconvulsive therapy have failed.”
Drs. Mayberg and Lozano conducted the first study of deep brain stimulation (DBS) for depression in Toronto, Canada, in 2003 and published their findings in Neuron in March 2005. As reported in this journal article, imaging studies led them to an area of the brain thought to be involved in depression called Brodmann Area 25. This area appears to become overactive when people are profoundly sad and depressed.
St. Jude Medical owns the intellectual property rights and has various patents pending for the use of neurostimulation at Brodmann Area 25. The Libra® Deep Brain Stimulation System, which is being evaluated in this study, is designed to deliver mild electrical pulses 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. Of these, only about 80 percent can be effectively treated with currently available therapies, according to the National Advisory Mental Health Council. Unfortunately, that means approximately 4 million adult Americans live with depression that does not respond to medications, psychotherapy and, in certain cases, electroconvulsive therapy.
“St. Jude Medical is dedicated to researching and developing neuromodulation therapies for people who live with conditions such as severe depression,” said Chris Chavez, president of St. Jude Medical’s ANS Division. “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.”
To be eligible for the study, participants must:
- Currently be diagnosed with major depressive disorder
- Be between 21 and 70 years old, with onset of first episode before age 45
- Have tried at least four treatments in their current episode, such as different medications, various combinations of medications or electroconvulsive therapy
- Have been depressed for at least one year
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).
Forward-Looking Statements
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 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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