Results of Brodmann Area 25 Deep Brain Stimulation Pilot Study Offer Hope for Patients...

Mon May 5, 2008 3:30pm EDT
 
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Results of Brodmann Area 25 Deep Brain Stimulation Pilot Study Offer Hope for Patients with Severe Depression

  Study findings presented today at American Psychiatric Association
                            Annual Meeting
ST. PAUL, Minn.--(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ) today announced pilot study
results from the first multi-center study investigating deep brain
stimulation (DBS) of Brodmann Area 25 for major depressive disorder.

   Results of the study, which were presented today at the American
Psychiatric Association (APA) meeting in Washington, D.C., found that
6 months after the procedure, 56 percent of the patients experienced
at least a 40 percent decrease in depressive symptoms. Patient's
symptoms were measured using a standardized test called the Hamilton
Rating Scale for Depression.

   Results were presented by Sidney Kennedy, M.D.,
psychiatrist-in-chief with the University Health Network in Toronto.
"Severe depression destroys a person's ability to be productive and
have a normal quality of life," said Dr. Kennedy. "The results from
this study are very promising, and we are hopeful that our research
will lead to a therapy that can help these patients."

   Prior to beginning the study, all patients were classified as
having severe depression after multiple treatments - such as
medications, psychotherapy and electroconvulsive therapy - had failed
to provide sustained relief from depression. Each study patient had
tried a minimum of 12 depression medications over his or her lifetime.

   DBS was targeted at an area of the brain known as Brodmann Area
25, which appears to become overactive when people are profoundly sad
and depressed. Conducted at three leading Canadian academic medical
centers, the study expands and supports the groundbreaking research of
Helen Mayberg, M.D., and Andres Lozano, M.D., which was published in
Neuron in March 2005.

   On average, the 20 study participants had suffered from depression
for more than 20 years; they were disabled and unable to work at the
time of enrollment. The study also found that:

   --  At their most recent psychiatric evaluation, 78 percent of the
        patients experienced at least a 40 percent decrease in
        depressive symptoms.

   --  Three of the study patients are considered to be in remission.

   --  Eight patients have re-engaged in life activities such as
        work, school, relationships and travel.

   In the study, DBS was delivered through the St. Jude Medical
Libra(R) Deep Brain Stimulation System, which delivers mild electrical
current from a device implanted near the collarbone; the device is
connected to small electrical leads placed at specific targets in the
brain.

   "These results are important as they help establish the body of
evidence that will continue to move depression research forward," said
Chris Chavez, president of the St. Jude Medical ANS Division. "We are
committed to leading the development of products that can make life
better for patients suffering from this debilitating condition."

   Based on the results of this research, St. Jude Medical announced
the BROADEN(TM) (BROdmann Area 25 DEep brain Neuromodulation) study in
February 2008, to further investigate the use of DBS for major
depressive disorder. A controlled, multi-center, blinded clinical
study, BROADEN is being conducted in the U.S. under an Investigational
Device Exemption (IDE) from the U.S. Food and Drug Administration
(FDA).

   St. Jude Medical owns the intellectual property rights and has
various patents issued and pending for the use of neurostimulation at
Brodmann Area 25. For more information about this clinical trial, call
toll-free 866-787-4332 or visit www.BROADENstudy.com.

   According to the National Advisory Mental Health Council, of the
21 million adult Americans who suffer from depression, approximately 4
million live with severe depression that does not respond to
medications, psychotherapy and, in certain cases, electroconvulsive
therapy.

   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 more than
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 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.

St. Jude Medical, Inc.
Investor Relations:
Angela Craig, 651-481-7789
or
Media Relations:
Kathleen Janasz, 651-415-7042
Mobile: 612-743-8995
or
Denise Landry, 972-309-8085

Copyright Business Wire 2008

 

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