Results presented today at the 14th annual North American
Neuromodulation Society meeting show that 70 percent of patients report
overall pain relief
ST. PAUL, Minn., Dec 03, 2010 (BUSINESS WIRE) --
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced two-year results in a post-market clinical study
(spinal cord stimulation) for the management of chronic
low back pain. Presented at the 14th annual North
American Neuromodulation Society (NANS) meeting in Las Vegas, the study
found that 70 percent of neurostimulation patients reported overall pain
relief of 50 percent or better at their final two-year visit.
Additionally, 88 percent of these patients reported that their quality
of life was improved or greatly improved.
"This study is the largest neurostimulation study conducted to date and
is specifically designed to gather more information about the
effectiveness of spinal cord stimulation for low back pain," said Dr.
Eugene Mironer, presenter of the results and managing partner of the
Carolina Center for Advanced Management of Pain in Spartanburg, S.C.
"Our findings at the two-year mark indicate that the therapy is
sustainable long-term. In addition to reporting an improvement in their
quality of life, 89 percent of patients were satisfied or very satisfied
with their results."
Neurostimulation therapy is a proven method of managing chronic pain. It
uses an implantable medical device to deliver mild electrical pulses to
the epidural space to mask or interrupt pain signals as they travel to
the brain. St. Jude Medical is sponsoring this research to continue to
build on the published data supporting the long-term sustainability of
"There is a growing body of evidence that confirms the effectiveness of
neurostimulation for the management of chronic pain, especially for
those patients who have tried multiple therapies only to continue to
suffer with pain," said Chris Chavez, president of the St. Jude Medical
Neuromodulation Division. "Over the course of the past decade, physician
training, technology improvement and patient selection criteria have
advanced greatly. Our study validates the significant impact of these
advances in further improving the effectiveness of neurostimulation
The large scale, prospective study was conducted at 29 medical centers
across the U.S. Preliminary analysis presented at NANS includes data
from 130 patients that have met the two-year follow-up point, since not
all patients have reached the two-year evaluation mark. The study design
utilizes the Eon(TM) rechargeable spinal cord stimulator and dual or
tripolar arrays of percutaneous leads or surgical leads.
Pain affects millions of people worldwide. In the U.S., more than 76.5
million people are categorized as suffering from pain by the American
Pain Foundation. Estimates by the National Institutes of Health
place the costs for lost work time and healthcare expenses at
approximately $100 billion every year.
For more than 30 years, the St. Jude Medical Neuromodulation Division
has developed new technologies to manage chronic
pain and other neurological disorders. Today more than 75,000
patients in 40 countries have been implanted with St. Jude Medical
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.
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 Quarterly Report on Form
10-Q for the fiscal quarter ended October 2, 2010. 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.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Denise Landry, 972-309-8085