St. Jude Medical Announces Australian TGA Regulatory Approval for Libra Deep Brain Stimulation Systems for Parkinson's Disease
July 14 2009 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced Australian
Therapeutic Goods Administration (TGA) approval of its Libra� and
LibraXP� deep brain stimulation (DBS) systems for treating the
symptoms of Parkinson�s disease, a neurological disorder that
progressively diminishes a person�s control over his or her
movements.
Similar to a heart pacemaker, the Libra DBS systems function by
delivering mild electrical pulses from an implanted device via thin
wires with multiple independent electrodes. The stimulation is
targeted to one of three regions in the brain which are involved in
muscle control for the symptomatic treatment of Parkinson�s
disease.
�This approval is an important step forward in bringing our deep
brain stimulation systems to a broader market,� said Chris Chavez,
president of the St. Jude Medical Neuromodulation Division. �We are
excited to be able to provide physicians in Australia with these
best-in-class deep brain stimulation systems, allowing them to have
more capability and control in treating their patients.�
The Libra and LibraXP neurostimulators are constant current
devices that feature the largest battery capacity of any DBS device
in their class, which may maximize the time between device
replacement procedures. This therapy can be externally programmed
by a clinician to meet individual patient needs.
An estimated 6.3 million people worldwide live with Parkinson�s
disease, 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. Parkinson's disease
affects both men and women in almost equal numbers, although
research suggests that men are two to three times more likely to be
diagnosed with the disease than women.
Parkinson�s Disease Symptoms
Parkinson�s disease patients may experience stiffness or
rigidity of the arms and legs, slowness or lack of movement, and
walking difficulties, in addition to tremor of the hands, arms,
legs, jaw or face. These symptoms can make simple, everyday tasks
like getting dressed, shaving, eating with utensils and drinking
from a glass difficult. Faced with these challenges, Parkinson�s
disease patients often have a significant decline in their quality
of life.
In addition to the TGA approval, the Libra and LibraXP DBS
systems have also received the CE Mark approval in Europe. In the
U.S., the systems are currently being evaluated in clinical studies
for depression, Parkinson�s disease and essential tremor. For more
information about these studies, visit www.BROADENstudy.com,
www.PowerOverPD.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 approximately 14,000 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 Report on Form 10-Q for the fiscal quarter
ended April 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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