With the new Infinity DBS System and directional lead, St. Jude
Medical has answered the call for more patient-centric, intuitive
technology for patients battling Parkinson’s disease, tremor and
dystonia
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced CE Mark approval for the St. Jude Medical
Infinity™ Deep Brain Stimulation (DBS) System and directional DBS
lead. The St. Jude Medical Infinity DBS system, which will be
available in two sizes, is the only upgradeable DBS system
available to patients battling movement disorders. The system uses
Bluetooth® wireless technology to communicate between the St. Jude
Medical Infinity DBS platform and Apple™ digital devices used as
patient and physician controllers. Combined, the features of the
system provide an improved, more intuitive experience for patients
suffering from Parkinson’s disease, tremor and dystonia, a disorder
which causes involuntary muscle contractions.
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The St. Jude Medical Infinity DBS system,
which will be available in two sizes, is the only upgradeable DBS
system available to patients battling movement disorders. (Photo:
St. Jude Medical)
Movement disorders are neurologic conditions that develop as
communications breakdown throughout a patient’s central nervous
system, leading to a debilitating lack of muscle control,
involuntary movement, and reduced coordination. With no proven
cure, treatments for movement disorders often focus on alleviating
the symptoms associated with each condition to improve quality of
life. Combined, Parkinson’s disease, dystonia and tremor represent
the three most common movement disorders in the world.
DBS systems deliver mild electrical pulses to specific targets
in the brain to stimulate the structures involved in motor control.
The systems consist of a surgically-implanted neurostimulator that
generates the electrical pulses and thin wires called leads which
carry the pulses to the brain to influence the irregular nerve
signals responsible for many of the symptoms of movement
disorders.
Conventional DBS leads have a limited ability to steer current
directionally, which can be challenging for physicians trying to
provide effective stimulation to specific areas of the brain. The
St. Jude Medical Infinity DBS system operates in conjunction with
the company’s newly-approved directional DBS lead, which allows
physicians to shape the therapy to a patient’s specific needs while
avoiding stimulation to areas that may create side effects. St.
Jude Medical designed the Infinity platform and directional lead
based on physician feedback demonstrating a clear need for improved
stimulation targeting, device longevity and a maintenance free,
non-rechargeable battery.
“The Infinity DBS system, including our directional lead and
wireless technology, represents a major step forward in our DBS
product portfolio, demonstrating St. Jude Medical’s commitment to
patient-centric solutions to help alleviate the debilitating
effects of movement disorders,” said Eric Fain, M.D., group
president at St. Jude Medical. “Not only are we able to offer
therapy solutions for a broad set of indications for movement
disorders, but we’ve also designed the system to provide patients
the best possible experience with their therapy while helping
physicians manage their patients more efficiently and
effectively.”
According to the European Brain Council, 1.2 million Europeans
suffer from Parkinson’s disease. Other statistics indicate that
more than 500,000 people battle some form of dystonia and an
estimated 14 percent of people over 65 suffer from essential
tremor, the most common form of tremor.
The St. Jude medical Infinity DBS system was designed to
transform the standard of care for movement disorder patients by
incorporating a number of patient-centric features. Because the
Infinity system is upgradeable, St. Jude Medical offers patients
the ability to retain access to the latest technology and therapy
options and new modes of stimulation as they are approved via
software upgrades, avoiding the need to undergo repeat surgery. St.
Jude Medical has also developed technology to allow patients with
existing DBS systems from any manufacturer to replace their
existing system to take advantage of the advancements enabled by
the Infinity system.
In addition, patients will now be provided an Apple iPod Touch™
digital device that allows them to easily manage their therapy.
Physicians will program their patient’s devices through an iPad
Mini™ digital device. The St. Jude Medical patient and physician
programmers use Bluetooth® wireless technology, providing a secure,
safe, and wireless experience.
“The new St. Jude Medical Infinity DBS system is enabling
physicians to improve management of our patient’s symptoms so we
can tailor our therapy approach and provide optimal treatment
solutions unique to the patient,” said Dr. Jan Vesper, a professor
of functional neurosurgery and stereotaxy at Heinrich Heine
University in Dusseldorf, Germany, and president of the German
Neuromodulation Society. “In addition to the benefits associated
with the new Infinity platform, with the St. Jude Medical
directional lead physicians will have access to a tremendous leap
forward in technology that has the potential to support improved
patient outcomes and potentially reduce side effects.”
Note: Apple, iPod Touch and iPad Mini are trademarks of Apple,
Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St.
Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com or
follow us on Twitter @SJM_Media.
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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. 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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorBarbara Van Buyten, +32 473 55 34
82Media Relationsbvanbuyten@sjm.com
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