St. Jude Medical Announces Approval and Market Launch of New Neurostimulation Lead to Manage Chronic Pain in Japan
October 06 2011 - 9:30PM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced regulatory approval from the Japanese
Ministry of Health, Labor and Welfare (MHLW) of the Penta™ surgical
lead for neurostimulation therapy to manage chronic pain.
St. Jude Medical, Inc. has announced
regulatory approval from the Japanese Ministry of Health, Labor and
Welfare (MHLW) of the Penta(TM) surgical lead for neurostimulation
therapy to manage chronic pain. The Penta surgical lead addresses
complex pain patterns like low back pain and arm and leg pain. In
addition to Japan, the Penta lead is also available in the U.S.,
Europe, Australia and Canada. (Photo: St. Jude Medical, Inc.)
The Penta surgical lead addresses complex pain patterns like low
back pain and arm and leg pain. Arranged in five columns, the lead
is designed to selectively stimulate nerve fibers associated with
the patient’s area of pain without affecting other areas. The Penta
lead features a proprietary micro-texturing process that enables
greater amounts of current to be delivered via the small
electrodes.
The Penta surgical lead can be used with the St. Jude Medical
Eon Mini™ spinal cord stimulator. Approximately the size of a man’s
watch, the Eon Mini neurostimulator’s thin, small design makes it
well suited for those patients whose body type requires a small
device. In addition to Japan, the Penta lead is also available in
the U.S., Europe, Australia and Canada.
“We are proud to be the first in the industry to offer
physicians a neurostimulation lead with broad lateral coverage to
help patients manage their chronic pain,” said William Phillips,
president of St. Jude Medical Japan. “The Penta lead provides the
most comprehensive spinal cord coverage available, and it is
another powerful addition to our expanding line of neurostimulation
products.”
Chronic pain is a largely under-treated and misunderstood
condition that affects millions of patients worldwide. The World
Health Organization, in conjunction with the International
Association for the Study of Pain (IASP), reports that as many as
one in five people suffers from moderate to severe chronic
pain.
Neurostimulation (also called spinal cord stimulation) is used
for managing chronic pain of the trunk and limbs and pain from back
surgeries that have failed. Using mild electrical pulses to
interrupt or mask the pain signals as they travel to the brain, the
neurostimulator can be programmed to meet each individual patient’s
needs. More information can be obtained about neurostimulation
therapy at www.PowerOverYourPain.com.
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 July 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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