With BurstDR stimulation, St. Jude Medical is providing chronic pain
patients a new therapy option designed to provide less pain, less
suffering and less therapy maintenance
ST. PAUL, Minn.--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced U.S. approval of BurstDR™ stimulation, a
physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior
outcomes for patients with chronic pain over traditional SCS therapy.
With FDA approval of BurstDR stimulation, which is exclusive to St. Jude
Medical, the company aims to help patients find relief from their pain
and suffering while also providing patients a better experience with
their chronic pain therapy.
Chronic pain is a complex and challenging condition for physicians to
manage, and a heavy burden for patients who find their lives profoundly
limited by their pain. Many patients often move from treatment option to
treatment option seeking pain relief, only to find a partial or
incomplete response to therapy.
Fortunately, SCS therapy can transform quality of life for many people
who are otherwise unable to find relief from chronic pain. BurstDR
stimulation from St. Jude Medical has been clinically proven to improve
upon traditional SCS by generating superior pain relief. With BurstDR
stimulation, St. Jude Medical is also helping physicians address their
patients’ physical and emotional responses to pain and reduce overall
pain and suffering as measured by patients who reported their responses
to therapy with BurstDR stimulation through visual analogue scale (VAS)
scoring.
“As a physician, reducing the physical sensation of pain experienced by
my patients is only part of my job; my ultimate goal is to help patients
overcome both the physical pain and the suffering associated with their
pain,” said Dr. Timothy R. Deer, president and chief executive officer
of The Center for Pain Relief in Charleston, West Virginia. “Now, with
BurstDR stimulation, St. Jude Medical has armed physicians with a new
therapy option that can reduce patients’ pain and suffering, reduce
paresthesia and help us offer our patients a more complete pain
management option.”
St. Jude Medical’s proprietary BurstDR stimulation works differently
from other stimulation designs, utilizing intermittent “burst” pulses
designed to mimic the body’s natural nerve impulse patterns. While other
companies have tried to mimic burst patterns, BurstDR stimulation from
St. Jude Medical is the only approved form of burst stimulation to have
been evaluated in a large scale, multicenter randomized controlled
clinical trial.
The St. Jude Medical BurstDR stimulation was introduced after nearly a
decade of research and study in collaboration with Prof. Dirk De Ridder,
who filed the therapy’s initial patents in 2004. BurstDR stimulation was
evaluated within the SUNBURST study, a prospective, randomized
multicenter study which confirmed BurstDR stimulation offered superior
pain relief over traditional SCS and that the therapy was preferred by
most patients over traditional SCS therapy. In addition, BurstDR
stimulation from St. Jude Medical has been studied in a large number of
international real world studies that have helped the company assess the
benefits of the therapy in patients worldwide.
“I am very excited that patients across the United States will now have
access to BurstDR stimulation, which has enjoyed strong success across
other global markets,” said Prof. De Ridder, from the University of
Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my
goal was to introduce an entirely new therapy option, and one that was
rooted in the natural way in which the human body responds to and
combats the sensation of pain.”
With FDA approval of BurstDR stimulation, patients receiving new
implants of the St. Jude Medical Proclaim™ Elite and Prodigy MRI™ spinal
cord stimulation systems will have immediate access to the new therapy.
Combined, the Proclaim Elite SCS System and BurstDR stimulation offers
patients the advantages of the St. Jude Medical Invisible Therapy™
portfolio and an entirely recharge free option, allowing patients to
focus on their lives instead of their pain. In addition, patients
previously implanted with upgradeable Protégé™ and Proclaim SCS systems
will soon be able to upgrade their systems to deliver BurstDR
stimulation without additional surgery.
“Chronic pain is one of the most costly epidemic diseases facing health
care systems worldwide, and one of the most challenging for physicians
to manage due to the complexity of the condition and the differences in
each patient’s clinical case,” said Allen W. Burton, M.D., medical
director of neuromodulation and vice president of medical affairs at St.
Jude Medical. “With FDA approval of BurstDR stimulation, we are
empowering physicians with a new therapy option in their fight against
widespread chronic pain, and our goal is to continue to improve patient
outcomes and get more patients the pain relief they deserve.”
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 is an international leader in
the development of chronic pain therapy solutions and the only medical
device manufacturer in the world to offer radiofrequency ablation (RFA)
and spinal cord stimulation (SCS) therapy solutions including BurstDR
stimulation and stimulation of the dorsal root ganglion (DRG) for the
treatment of chronic pain.
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, reimbursement strategies, 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
2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended
July 2, 2016. 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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Source: St. Jude Medical, Inc.
