St. Jude Medical Announces First Patient Implants in Clinical Study Evaluating Deep Brain Stimulation for Depression
June 26 2008 - 8:00AM
Business Wire
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� Deep Brain Stimulation System, an
investigational device. The study, called BROADEN� (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.
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