First patient implanted with Brio neurostimulator at University of
Cologne, Germany
ST. PAUL, Minn.--(BUSINESS WIRE)--Sep. 9, 2009--
St. Jude Medical, Inc. (NYSE:STJ) today announced CE (Conformité
Européenne) Mark approval of the Brio™ neurostimulator,
the world’s smallest, longest-lasting rechargeable deep brain
stimulation (DBS) device for treating the symptoms of Parkinson’s
disease. A 67-year-old man who has suffered from Parkinson’s disease for
more than 26 years became the first person to be implanted with the Brio
neurostimulator.
Slightly larger than the typical man’s watch, the Brio neurostimulator
has a thin 10 mm profile and weighs 29 grams (approximately 1 oz).
Additionally, the device has the greatest recommended implant depth of
any rechargeable DBS device. The thin profile and greater implant depth
potentially makes the neurostimulator less noticeable and more
comfortable for patients.
“Deep brain stimulation therapy is often the preferred treatment for
many Parkinson’s disease patients,” said Professor Dr. Volker Sturm,
chairman of neurosurgery at the University Hospital of Cologne. “For
these patients, device size and longevity are important considerations.
The small size of the Brio neurostimulator is a real improvement and was
a good choice for this patient.”
The procedure was performed by Professor Sturm’s colleague, Dr. Mohammad
Maarouf, at the University Hospital of Cologne.
The Brio DBS system delivers mild electrical pulses to specific targets
in the brain, stimulating the structures that are involved in motor
control. The system consists of a neurostimulator – a surgically
implanted battery-operated device that generates the electrical pulses –
and leads which carry the pulses to the brain to influence the irregular
nerve signals responsible for the symptoms of Parkinson’s disease.
“The Brio neurostimulator is an important addition to our family of deep
brain stimulation systems,” said Chris Chavez, president of the St. Jude
Medical Neuromodulation Division. “We are excited to offer physicians a
best-in-class product to help them meet the needs of patients who
require a smaller, long-lasting rechargeable system in order to better
control the symptoms of this debilitating disease.”
In addition to its small size, the Brio neurostimulator has the longest
battery life of any rechargeable DBS device currently on the market with
a 10-year battery longevity approval. For patients this means the device
should provide sustainable therapy and maintain a reasonable recharge
interval for at least 10 years of use at high settings. The device’s
battery longevity may also maximize the time between device replacement
procedures.
The Brio neurostimulator also features:
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Constant current circuitry that automatically adjusts to deliver
consistent therapy over time.
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A dual header that accommodates two leads, allowing for bilateral
stimulation from one device.
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High power capability, making it an appropriate choice for patients
who require high energy settings to control their symptoms.
-
A rechargeable battery that can be easily charged through a portable,
wireless charging system, allowing patients the freedom to recharge
comfortably while doing other activities.
Additionally, St. Jude Medical has recently received CE Mark approval
for the Guardian™ Burr Hole Cover System, a DBS system component that
allows physicians to efficiently secure the electrical leads. The
Guardian System is compatible with all St. Jude Medical DBS leads.
Parkinson’s disease affects an estimated 6.3 million people worldwide,
according to the European Parkinson’s Disease Association. The disease
usually develops in people between the ages of 40 and 70, with an
average age of onset of 60 years.
St. Jude Medical is also currently developing new DBS applications to
address a growing list of neurological and psychiatric disorders.
Clinical studies are underway in the U.S. for depression and essential
tremor. For more information about these studies, visit www.BROADENstudy.com
and www.PowerOverET.com.
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 15,000 people worldwide 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 Quarterly Reports on
Form 10-Q for the fiscal quarters ended April 4, 2009 and July 4, 2009.
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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Source: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Investors
Angela Craig,
651-481-7789
acraig@sjm.com
or
Media
Denise
Landry, 972-309-8085
dlandry@sjm.com
