After 12 months, the ACCURATE study confirmed the benefits of DRG
stimulation over traditional SCS for patients with complex regional pain
syndrome or peripheral causalgia
ST. PAUL, Minn. & LAS VEGAS--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced long term data from the ACCURATE study has confirmed
dorsal root ganglion (DRG) stimulation with the St. Jude Medical Axium™
Neurostimulator System provides sustained and superior pain relief over
traditional spinal cord stimulation (SCS) in patients with complex
regional pain syndrome (CRPS) or peripheral causalgia (PC). In addition,
patients receiving DRG stimulation reported better therapeutic targeting
and a reduction in paresthesia (the tingling feeling common to
traditional SCS) compared to traditional tonic SCS.
The data were presented today during a plenary session at the 19th
annual meeting of the North American Neuromodulation Society (NANS) in
Las Vegas, Nevada, and confirm three month primary endpoint data
originally presented at the International Neuromodulation Society (INS)
annual meeting in June 2015.
“DRG stimulation represents hope to many patients eager for more
meaningful treatment options for complex and hard-to-treat neuropathic
chronic pain conditions,” said Robert Levy, M.D., director of the Marcus
Neuroscience Institute in Boca Raton, Florida, and co-principal
investigator of the ACCURATE study. “The data from the ACCURATE study
have shown us that DRG stimulation yields long term meaningful pain
relief for patients with complex regional pain syndrome and peripheral
causalgia. The results of this trial are very exciting for those of us
who treat patients with these debilitating conditions.”
Long-term, 12-month data from the ACCURATE study showed DRG stimulation
Sustained and superior pain relief: After 12 months, the
ACCURATE study demonstrated a statistically significantly number of
patients receiving DRG stimulation achieved meaningful pain relief and
greater treatment success when compared to patients receiving
traditional SCS (74.2 percent vs. 53 percent).
Improved therapeutic targeting: Nearly all patients receiving
DRG stimulation reported better stimulation targeting in their area of
pain without extraneous paresthesia than patients receiving
traditional SCS (94.5 percent vs. 61.2 percent).
Reduced paresthesia: After 12 months, more than a third of
patients who received DRG stimulation were experiencing greater than
80 percent pain relief with no paresthesia.
“The long term data from the ACCURATE trial further confirm that DRG
stimulation with the St. Jude Medical Axium system can provide sustained
and superior outcomes for patients suffering from chronic pain
conditions that are currently very challenging to treat using
traditional spinal cord stimulation,” said Allen Burton, M.D., medical
director of neuromodulation and vice president of medical affairs at St.
Jude Medical. “Patients battling complex regional pain syndrome and
peripheral causalgia have very few options, and we believe DRG
stimulation will provide a meaningful treatment option to patients
suffering from these conditions.”
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. Research has suggested that, in total, the condition costs the
American population an estimated 515 million workdays annually and
generates upwards of 40 million visits to physicians each year.
Neuropathic pain represents one of the most prevalent yet under-treated
forms of chronic pain in the U.S., with an estimated one in every 10
adults over the age of 30 suffering from the condition. By targeting the
DRG, a spinal structure densely populated with sensory nerves that
transmit information to the brain via the spinal cord, the St. Jude
Medical Axium system has been shown to provide pain relief to patients
with neuropathic conditions currently underserved by traditional SCS.
The ACCURATE study represents the largest study to date evaluating
patients suffering from neuropathic chronic lower limb pain associated
with CRPS or PC. St. Jude Medical submitted their premarket approval
(PMA) submission to the FDA for approval of DRG stimulation in Q1 2015.
The Axium Neurostimulator System has been available in Europe since 2011.
Additionally, St. Jude Medical will be hosting an investor event at the
NANS Conference Friday, December 11th starting at 3:00pm PST.
The event will include a presentation highlighting St. Jude Medical’s
Neuromodulation portfolio and clinical data presented at NANS followed
by a Q&A period. A live webcast of the event will also be available via
Relations section of the St. Jude Medical website (http://investors.sjm.com/).
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 Burst
stimulation and stimulation of the dorsal root ganglion (DRG)* for the
treatment of chronic pain.
*Caution: Investigational device. Limited by Federal law to
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.
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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151211005787/en/
Source: St. Jude Medical, Inc.