St. Jude Medical Neurostimulation Study Demonstrates Sustained Improvement in Chronic Low Back Pain Symptoms and Quality of Life
December 03 2010 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced two-year results in a post-market clinical
study evaluating neurostimulation (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 the therapy.
“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 therapy.”
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™ 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
neurostimulation systems.
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.
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 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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