St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for Depression
July 11 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted approval for expansion of its BROADEN™
(BROdmann Area 25 DEep brain Neurostimulation) study for depression.
This expansion will allow a maximum of 20 sites across the U.S. to
enroll up to 125 patients.
The Libra(TM) deep brain stimulation
system is an investigational device being tested in clinical
research studies for major depressive disorder. The Libra system
sends mild electrical pulses to a specific target in the brain from
a device implanted in the chest. This device was developed by St.
Jude Medical, Inc. Caution: Investigational device, limited by
United States law to investigational use. (Photo: Business
Wire)
The BROADEN study is investigating whether or not stimulating an
area of the brain known as Brodmann Area 25 (BA25) with a deep
brain stimulation (DBS) system is a safe and effective method for
treating severe depression.
“Deep brain stimulation could potentially change the way that we
look at treating patients suffering with severe depression,”
said Mark George, M.D., distinguished professor of
psychiatry, radiology and neurology at the Medical University
of South Carolina. “Treatments such as medications, psychotherapy
and electroconvulsive therapy often fail to work for these very
difficult-to-treat patients, so we are hopeful this research will
provide us with a new approach to treating this debilitating
condition.”
The BROADEN study is a controlled, blinded study that utilizes
the St. Jude Medical Libra™ deep brain stimulation system. Prior to
the expansion, this study was conducted at only three centers
located in Chicago, New York City and Dallas. Participants must be
classified as having treatment-resistant depression and must have
failed multiple treatments to be a candidate for the study.
“We are committed to leading this important research in hopes of
finding a solution for people who currently don’t have a treatment
option,” said Chris Chavez, president of the St. Jude Medical
Neuromodulation Division. “By expanding the BROADEN study, we are
able to continue to add to the body of evidence that will determine
if deep brain stimulation is indeed an option for managing major
depressive disorder.”
The BROADEN study is being conducted under a U.S. Food and Drug
Administration (FDA) Investigational Device Exemption (IDE). St.
Jude Medical will request approval to expand the study to a total
of 231 patients at a later date. To locate participating centers,
please visit www.BROADENstudy.com or call toll-free
866-787-4332.
To be eligible for this study, participants must:
- Have been diagnosed with major
depressive disorder (MDD)
- Be between 21 and 70 years old
- Have had first depressive episode
before age 45
- Have tried at least four treatments in
their current episode (for example, different medications,
different combinations of medications, and/or electroconvulsive
therapy (ECT))
The BROADEN study builds upon an earlier St. Jude Medical pilot
study which reported that at six months, 62 percent of the patients
experienced at least a 40-percent decrease in symptoms of
depression as measured by a standardized test called the Hamilton
Rating Scale for Depression. Of these patients, 92 percent
maintained this improvement at their last follow-up visit
(typically at one year).
A non-pharmacological therapy, deep brain stimulation uses mild
pulses of current from an implanted device to stimulate the brain.
DBS leads are surgically positioned in the brain at a specific
target and connected with a neurostimulator that is typically
placed under the skin near the collarbone.
In the U.S., more than 21 million adults suffer from some kind
of depressive disorder, according to the National Institute of
Mental Health (NIMH). Of these, approximately 4 million live with
severe depression that does not respond to medications,
psychotherapy and, in certain cases, ECT.
Three Decades of Leading-Edge Neurostimulation
Technology
For more than 30 years, the St. Jude Medical Neuromodulation
Division has developed new technologies to treat chronic pain and
other neurological disorders. Today more than 75,000 patients in 40
countries have been implanted with St. Jude Medical
neurostimulation systems.
Focused on research, St. Jude Medical is developing new
technologies to address a growing list of neurological disorders.
Clinical studies are currently underway for Parkinson’s disease,
essential tremor, migraine headache, and others.
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. St. Jude Medical is headquartered in
St. Paul, Minn., and has four major focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit 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
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2011. 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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