St. Jude Medical Announces FDA Clearance for Industry-First Neurostimulation Lead Delivery System for the Management of Chron...
July 12 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the U.S. Food and Drug Administration
(FDA) clearance and limited market release of the Epiducer™ lead
delivery system for neurostimulation therapy. This
first-of-its-kind system allows physicians to place multiple
neurostimulation leads through a single entry point.
The first-of-its-kind Epiducer(TM) lead
delivery system enables physicians to place multiple
neurostimulation leads through a single entry point.
Neurostimulation leads are utilized in spinal cord stimulation
(SCS) therapy for the management of chronic pain. Image provided by
St. Jude Medical, Inc.
Designed to reduce procedural complexities and enhance
efficiency, the Epiducer lead delivery system reduces the need for
multiple incisions typically required to place more than one
neurostimulation lead utilized in spinal cord stimulation (SCS)
therapy for the management of chronic pain. The system also allows
physicians to introduce St. Jude Medical S-Series™ paddle leads
through a percutaneous entry. Before the Epiducer system, the
placement of paddle leads was only possible through a laminotomy, a
more invasive surgical procedure that typically requires removal of
part of the vertebral bone.
In addition, this minimally invasive system enables physicians
to deliver one, two or three different leads through a single entry
point to configure and optimize the therapy for each patient. This
allows for the management of complex and multifocal pain patterns
such as low back pain combined with leg pain.
“The Epiducer lead delivery system represents an important
paradigm shift and step forward enabling physicians to configure
patient-specific systems utilizing multiple lead arrays to treat
complex multifocal pain, and we are excited to bring it to the U.S.
market,” said Chris Chavez, president of the St. Jude Medical
Neuromodulation Division. “This innovative system is already
available in Europe, Australia and Canada, and physician feedback
has been very positive regarding this new capability to deliver
multiple lead configurations less invasively.”
Created with a highly radiopaque material to provide easy
fluoroscopic visualization, the Epiducer system is the newest
addition to the St. Jude Medical product portfolio which includes
many industry firsts including:
- World’s smallest neurostimulator for
chronic pain – the Eon Mini™ spinal cord stimulator
- First-of-its-kind five-column paddle
lead – the Penta™ lead
- Unique mechanical locking lead anchor
designed to enhance procedural efficiency – the Swift-Lock™
anchor
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. Mild electrical pulses are carried from
the neurostimulator to a lead or leads that are placed in the
epidural space near the spine to interrupt or mask the transmission
of pain signals to the brain. Electrodes on the lead can be
programmed to meet each individual patient’s needs. More
information can be obtained about neurostimulation therapy at
www.PowerOverYourPain.com.
Chronic pain affects millions worldwide. According to a new
report from the Institute of Medicine (IOM) of the National
Academies, chronic pain affects an estimated 116 million American
adults — more than the total affected by heart disease, cancer, and
diabetes combined. Pain also costs the nation up to $635 billion
each year in medical treatment and lost productivity. Noting that
much of this pain is preventable or could be better managed, the
IOM report calls for coordinated national efforts of public and
private organizations to create a cultural transformation in how
the nation understands and approaches pain management and
prevention. The study was mandated by Congress and sponsored
by the National Institutes of Health. The IOM provides independent,
objective, evidence-based advice to policymakers, health
professionals, the private sector, and the public. Visit the
IOM site for more on their “Relieving Pain in America” report.
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 or
results being reported currently for Parkinson’s disease, essential
tremor, migraine headaches, major depressive disorder, 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 April 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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