St. Jude Medical Receives CE Mark for Industry's Only MR-Conditional Rechargeable Spinal Cord Stimulator Approved to Offer Bu...
August 24 2015 - 8:30AM
Business Wire
New MRI approval for the Prodigy MRI system ensures patient
access to St. Jude Medical’s chronic pain products
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced CE Mark approval for magnetic resonance
imaging (MRI) conditional labeling for the company’s Prodigy MRI™
chronic pain system with select leads. Upon its launch, the Prodigy
MRI system will become the market’s smallest MR-conditional
rechargeable implantable pulse generator (IPG), as well as the
industry’s sole MR-conditional SCS system capable of delivering
both St. Jude Medical’s proprietary Burst stimulation and
traditional tonic stimulation.
In addition to the approval of Prodigy MRI, all Octrode™
percutaneous and Penta™ 5-column paddle leads have received
MR-conditional labeling and are approved for use with Prodigy MRI.
The Penta lead is the industry’s only five-column paddle lead,
which offers unmatched lateral coverage to finely control current
and stimulate spinal nerves based specifically on patient need.
Nearly 95 million Europeans suffer from chronic pain, and the
condition costs European health care systems a combined total of
300 billion Euro annually due to associated medical costs, lost
work days and social security and welfare payments. SCS therapy can
offer many patients meaningful pain relief and improvements in
quality of life, yet for some patients the need for future MRI
scans can act as a barrier to SCS therapy.
The new Prodigy MRI system will ensure patient access to St.
Jude Medical’s innovative portfolio of chronic pain solutions, such
as the company’s Burst stimulation, while maintaining the option
for patients who may need future head and extremity MRI scans. In
addition to the approval of the Prodigy MRI system, St. Jude
Medical has announced plans to seek updated labeling in key markets
around the world for additional chronic pain products, and plans to
submit testing data to support full-body MR-conditional labeling
for their future SCS systems.
“Clinical experience suggests that while relief from chronic
pain remains the primary need for patients seeking spinal cord
stimulation therapy, some patients who may benefit from SCS therapy
may also need future MRI scans,” said Dr. Athanasios Koulousakis,
Head of Department Functional Neurosurgery, Spasticity and Pain,
University Hospital in Cologne, Germany. “So while the number of
SCS patients requiring future MRIs may be limited, it is still
critical to remove barriers to diagnostic options. Yet just as
critical is providing MRI capability in SCS solutions that provide
access to new therapy options, such as St. Jude Medical’s Burst
stimulation. The new Prodigy MRI system helps put all such
requirements into one package for our patients.”
St. Jude Medical is the only company approved to offer patients
Burst stimulation, which the company introduced to the market in
2014 with the launch of the original Prodigy™ chronic pain system.
The therapy was introduced after nearly a decade of research and
study in collaboration with Dr. Dirk De Ridder, who filed the
therapy’s initial patents in 2005.
The addition of Burst stimulation to St. Jude Medical’s chronic
pain portfolio offered patients access to a therapy proven to
relieve pain more effectively than traditional SCS while also
significantly reducing or eliminating paresthesia for most
patients. Clinical studies have also shown Burst stimulation can
also offer pain relief to patients who may have become unresponsive
to traditional SCS.
“MRI compatibility in our Prodigy system answers a growing
market demand for devices that enhance patient access to new
stimulation modes and therapy options,” said Eric S. Fain, M.D.,
group president of St. Jude Medical. “MRI compatibility for head
and extremity will reduce treatment limitations or restrictions for
chronic pain patients who may have future MRI needs. We want
patients to have access to the most advanced therapies and
technologies to effectively and safely reduce their chronic
pain.”
About the St. Jude Medical Chronic Pain Portfolio
Chronic 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 offers
multiple solutions for patients to manage debilitating chronic
pain, including spinal cord stimulation, targeted stimulation of
the dorsal root ganglion (DRG) and radiofrequency ablation
(RFA).
Spinal cord stimulation is a proven therapy used to manage
chronic pain. SCS therapy uses a small implanted generator to
deliver electrical pulses to the nerve fibers of the spinal column
via thin wires, known as leads with electrodes. These electrical
pulses mask or interrupt pain signals as they travel up the spinal
cord to the brain, reducing pain sensation.
About Burst Stimulation
St. Jude Medical’s Burst stimulation is a proprietary
neurostimulation waveform that functions independently from
stimulation cycles and programming currently available from other
SCS systems. Burst stimulation is engineered to mimic the natural
firing patterns of the nerves in the body, and delivers
closely-spaced pulses of electrical energy to a patient’s spinal
cord to manage chronic pain. St. Jude Medical has led rigorous
development and ongoing clinical study of Burst stimulation and is
the only company approved to offer Burst therapy.
Burst stimulation may be an option for patients whose pain is
not adequately controlled, or for those who lose therapeutic
benefit over time with tonic SCS alone. Early research indicates
that St. Jude Medical’s Burst stimulation may be able to deliver
SCS therapy with reduced paresthesia, and may be more effective
than tonic stimulation for some patients.
About St. Jude Medical
St. 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 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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 4, 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/20150824005146/en/
St. Jude Medical, Inc.Investor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsBarbara Van BuytenTel
32 2 774 67 12bvanbuyten@sjm.com
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