Healthcare Industry News:  deep brain stimulation 

Devices Neurosurgery Neurology

 News Release - February 11, 2009

UT Southwestern Performs First Local Implant in Deep Brain Stimulation Study for Depression

DALLAS--(HSMN NewsFeed)--UT Southwestern Medical Center neurological surgeons have begun implanting patients as part of a clinical study that is investigating whether deep brain stimulation (DBS) therapy may help people who suffer from major depressive disorder, a severe form of depression.

The BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) study is a controlled, multi-site, blinded, clinical study that is evaluating the safety and effectiveness of DBS therapy in patients with depression for whom currently available treatments are not effective. UT Southwestern is one of three U.S. sites currently participating in this clinical study.

The Libra® DBS system being evaluated in this study is designed to provide mild pulses of current to a part of the brain called Brodmann Area 25. This area appears to be overactive when people are profoundly depressed.

“Studies such as this are an important step in the development of new therapies. Treatment-resistant patients are those who have tried numerous medications to treat their depression. They feel hopeless and over many years, their quality of life has deteriorated,” said Mustafa Husain, M.D., professor of psychiatry and internal medicine at UT Southwestern and director of the UT Southwestern Neurostimulation Research Lab. “We are optimistic that this research will lead to a therapy that can provide these patients with some much-needed hope.”

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. That means approximately 4 million adult Americans live with depression that doesn’t respond to medications or psychotherapy.

“The Libra DBS system’s generator or ‘battery’ is implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain,” said Tony Whitworth, M.D., assistant professor of neurological surgery at UT Southwestern, who performed the implants. “The implantation surgery takes about two to three hours. Patients typically are able to go home one or two days after the procedure.”

The BROADEN study is sponsored by the Plano-based Neuromodulation Division of St. Jude Medical and is being conducted under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE).

For more information about this study, call toll-free 866-787-4332 or visit www.BROADENstudy.com. In the Dallas/Ft. Worth area, call 214-648-4622 or 214-648-2806.

Visit http://www.utsouthwestern.org/neurosciences to learn more about UT Southwestern’s clinical services in neurosciences.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.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 Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. 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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