St. Jude Medical Announces FDA Approval of the Proclaim Elite SCS System, a Patient-Centric, Recharge-Free, Upgradeable & MR-...
November 19 2015 - 8:00AM
Business Wire
By prioritizing convenience, comfort and pain relief, the
Proclaim™ Elite SCS System aims to shift patient focus from their
chronic pain therapy toward their quality of life
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company and an international leader in chronic pain therapy
development, today announced FDA approval of the new Proclaim™
Elite Spinal Cord Stimulation System, the first and only
upgradeable and recharge-free spinal cord stimulation (SCS) system
available to people in the U.S. suffering from chronic pain. The
approval also includes conditional magnetic resonance (MR) labeling
for the Proclaim Elite SCS system, which will allow patients to
safely undergo head and extremity MRI scans.
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The Proclaim Elite SCS System from St.
Jude Medical prioritizes patient convenience, comfort and pain
relief to shift patient focus from their chronic pain therapy
toward their quality of life. (Photo: Business Wire)
The current approval also includes the company’s new, innovative
clinician programmer, which allows clinicians to program and adjust
their patient’s spinal cord stimulation therapy with an Apple™ iPad
mini™ mobile digital device. In addition, patients will be able to
evaluate spinal cord stimulation with the St. Jude Medical™
Invisible Trial System, a discreet, app-based and wireless
neuromodulation programming system leveraging Apple™ iPad touch™
mobile digital devices.
“The approval of the Proclaim Elite recharge-free SCS system is
a needed advancement for both patients and physicians who now have
access to a low-maintenance chronic pain treatment that can reduce
interference with daily activities,” said Timothy R Deer, M.D.,
president and chief executive officer of The Center for Pain Relief
in Charleston, West Virginia. “In the last 10 years of SCS, we have
seen advances in rechargeable technology but less attention paid to
therapy compliance and how patients interact with their device. Now
with the Proclaim Elite SCS system we can offer
appropriate patients an optimal low-maintenance experience
while enabling access to future therapies without the need for
additional surgeries.”
According to the Institute of Medicine, chronic pain
affects more than 100 million Americans, an incidence rate which
outpaces heart disease, cancer and diabetes combined. Past research
has suggested that the condition can cost the American population
an estimated 515 million workdays annually and generates upwards of
40 million visits to physicians each year.
St. Jude Medical designed many elements of the Proclaim system
based on physician and patient feedback to ensure patients could
benefit from all aspects of the product. In particular, the
non-rechargeable system improves patient convenience by removing
the burden of regularly recharging the SCS system. The system’s
upgradable platform allows patients to access future SCS technology
upgrades, such as new stimulation waveforms and software updates,
without surgical device replacement. Historically, most patients
would need additional surgery to receive product upgrades as they
are approved.
With its latest round of SCS product offerings, St. Jude Medical
aims to further enhance ease-of-use and familiarity for patients by
leveraging Bluetooth® wireless technology and Apple™ mobile digital
devices for the Proclaim Elite SCS system’s patient controller and
clinician programmer. This approach will allow patients to interact
with their device more easily, which can ensure effective
management of their chronic pain treatment with minimal disruption
to their daily life.
“St. Jude Medical has a legacy of consistently advancing spinal
cord stimulation therapy options to our ensure chronic pain
patients are receiving innovative, patient-centric devices and
optimal therapy to manage their chronic pain,” said Allen Burton,
M.D., medical director of neuromodulation at St. Jude Medical. “The
new St. Jude Medical Proclaim Elite system bridges the gap between
today’s state-of-the-art therapies and tomorrow’s groundbreaking
innovations for chronic pain. The wireless platform is based on the
latest Apple technologies making it upgradeable to new therapies
for the future. With a discreet, hassle-free trial system and a
simple permanent implant procedure, this pioneering platform can
improve both the patient’s chronic pain and overall therapy
experience.”
Note: Apple, iPod touch and iPad Mini are trademarks
of Apple, Inc. Bluetooth is a trademark of Bluetooth
SIG, Inc.
About the St. Jude Medical Chronic Pain PortfolioChronic
pain affects approximately 1.5 billion people worldwide, more than
heart disease, cancer and diabetes combined. The condition can
negatively impact personal relationships, work productivity and a
patient’s daily routine. St. Jude Medical is an international
leader in the development of innovative chronic pain therapeutic
options and offers multiple solutions for patients to manage
debilitating chronic pain, including spinal cord stimulation,
spinal cord stimulation targeting the DRG and radiofrequency
ablation.
About St. Jude MedicalSt. 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 StatementsThis 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 October 3, 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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version on businesswire.com: http://www.businesswire.com/news/home/20151119005155/en/
St. Jude Medical, Inc.Investor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsJustin Paquette,
651-756-6293jpaquette@sjm.com
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