ST. PAUL, Minn.--(BUSINESS WIRE)--June 26, 2008--St. Jude Medical,
Inc. (NYSE:STJ) today announced the first patient implants in a
clinical study that is investigating whether deep brain stimulation
(DBS) therapy will help people who suffer from major depressive
disorder, a severe form of depression. The patients, a 59-year-old
woman and a 42-year-old man, were implanted at Alexian Brothers
Behavioral Health Hospital in Chicago, with the St. Jude Medical
Libra(R) Deep Brain Stimulation System, an investigational device.
The study, called BROADEN(TM) (BROdmann Area 25 DEep brain
Neuromodulation), is a controlled, multi-site, blinded study that is
evaluating the safety and effectiveness of DBS in patients with
depression for whom currently available treatments are not effective.
"We are excited to be part of the first double-blind study of Deep
Brain Stimulation for depression and remain hopeful that this therapy
may prove beneficial for this seriously ill patient population," said
Anthony D'Agostino, M.D., medical director of Alexian Brothers
Behavioral Health Hospital and the principal investigator at the study
site. "The study is an important contribution to the advancement of
treatment options for severely depressed patients."
This study is researching a specific area in the brain called
Brodmann Area 25 that is thought to be involved in depression. The
first research of DBS for depression was conducted in Toronto, Canada,
by neurologist Helen S. Mayberg, M.D., and neurosurgeon Andres Lozano,
M.D., in 2003. They published their findings in Neuron in March 2005,
reporting that brain imaging studies indicate that Brodmann Area 25
appears to be overactive in profoundly sad and depressed people.
St. Jude Medical owns the intellectual property rights, and has
various patents issued and pending, for the use of neurostimulation at
Brodmann Area 25. The Libra Deep Brain Stimulation System provides
mild pulses of current from a device implanted near the collarbone and
connected to small electrical leads placed at specific targets in the
brain.
"This depression study represents a continuation of our commitment
to provide solutions for those who are suffering and in need of
additional therapy options," said Chris Chavez, president of the St.
Jude Medical ANS Division. "The Brodmann Area 25 study is an important
step in bringing physicians and their patients a neuromodulation
therapy that, if successful, will treat this debilitating form of
depression."
The National Institute of Mental Health estimates that more than
21 million U.S. adults suffer from some kind of depressive disorder.
Current therapies are effective for about 80 percent of this patient
population according to the National Advisory Mental Health Council.
That means approximately 4 million adult Americans live with
depression that doesn't respond to medications, psychotherapy or
electroconvulsive therapy.
To be eligible for this 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 at
866-787-4332, visit www.BROADENstudy.com.
Sponsored by St. Jude Medical, the BROADEN study is being
conducted under a U.S. Food and Drug Administration (FDA)
investigational device exemption (IDE). Initial study centers are
located in Chicago, Dallas and New York City. This clinical study was
preceded by a smaller pilot study of 20 patients at three sites in
Canada which found that six months after the procedure, 56 percent of
the patients experienced at least a 40 percent decrease in depressive
symptoms. At last follow-up, 78 percent of the patients were
responders, and eight of the patients have re-engaged in life
activities such as work, school, travel and relationships, and three
of the study patients are considered to be in remission. Patients'
symptoms were measured using the Hamilton Rating Scale for Depression.
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
more than 12,000 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.
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 Risk
Factors and Cautionary Statements sections of the Company's Annual
Report on Form 10-K filed on February 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.
CONTACT: St. Jude Medical
Angela Craig, 651-481-7789
Investor Relations
or
Kathleen Janasz, 651-415-7042
Media Relations
or
Denise Landry, 972-309-8085
Media Relations
SOURCE: St. Jude Medical, Inc.
