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St. Jude Medical, a global medical device company, today announced the United States Food and Drug Administration approval and first implant of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) system and its DBS directional leads, the first directional lead approved in the United States.

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the United States Food and Drug Administration approval and first implant of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) system and its DBS directional leads, the first directional lead approved in the United States. Combined with the first
and only wireless iOS™ software platform
available to DBS patients and physicians, the St. Jude Medical Infinity system provides a discreet, personalized experience for patients suffering from Parkinson’s disease or essential tremor, while delivering targeted relief of only the necessary areas.
The Infinity DBS system was first implanted by Dr. Kelly Foote,
professor of neurosurgery and co-director of the University of Florida
Center for Movement Disorders and Neurorestoration at the UF Health
Shands Hospital.
Speaking about the new technology, Foote said, “I’m very happy that the
Infinity DBS system and its directional DBS lead are now available in
the U.S. I believe that the directional lead represents an important
advancement in DBS technology that has the potential to improve outcomes
of DBS therapy for many patients. This new system offers the potential
to diminish adverse effects of DBS by steering current away from areas
of the brain that cause side effects, allowing us to better control the
symptoms of Parkinson’s disease and essential tremor.”
The St. Jude Medical Infinity system is indicated to treat two of the
most common movement disorders — Parkinson’s disease and essential
tremor. Movement disorders are neurological conditions caused by a
communication breakdown throughout the central nervous system that can
result in a debilitating loss of muscle control, involuntary movement
and reduced coordination. There are currently no proven cures for
movement disorders, which means treatment options focus on alleviating
symptoms to improve quality of life.
“The new St. Jude Medical Infinity DBS system is an advanced technology
that has the potential to provide more choices to patients with
Parkinson’s disease and essential tremor,” said Dr. Michael S. Okun,
chairman of the department of neurology at UF College of Medicine and
the national medical director for the National Parkinson Foundation.
“The Infinity DBS system has a newly designed DBS lead with segmented
contacts, which can be used to tailor the DBS therapy approach for an
individual patient and to optimize benefits while reducing common
DBS-related side effects.”
The
St. Jude Medical Infinity system
also offers new, distinct patient
advantages such as being the world’s first and only DBS system operating
on a wireless iOS software platform. The system uses a clinician
programmer with an iPad mini™ mobile digital device and an iPod touch™
mobile digital device patient controller with Bluetooth® LE connectivity
that can expedite the programming process for the neurologist, while
offering patients a discreet experience. Conveniently, the system
battery is available in two different sizes to accommodate different
body types and offers a maintenance-free, long-lasting recharge-free
option for DBS therapy.
“The St. Jude Medical Infinity DBS system and directional lead represent
St. Jude Medical’s commitment to the treatment of debilitating movement
disorders,” said Dr. Allen Burton, medical director of neuromodulation
and vice president of medical affairs at St. Jude Medical. “The new St.
Jude Medical Infinitysystem was designed to streamline
therapy programming, allowing physicians more time to provide care to
more patients. The system was also designed to provide patients with the
best possible experience to manage their symptoms in a discreet manner
that fits more easily into their lives.”
For more information about St. Jude Medical’s focus on the treatment of
movement disorders, visit the patient website at www.sjm.com/DBS.
Note: Apple, iPod touch and iPad mini are trademarks of Apple,
Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc., iOS is
a trademark of Cisco Technology, Inc.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is
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 employs approximately 18,000 people worldwide and has five major
areas of focus that include heart failure, atrial fibrillation,
neuromodulation, traditional cardiac rhythm management and
cardiovascular. 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, reimbursement strategies, 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
2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended
July 2, 2016. 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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