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|St. Jude Medical Neurostimulation Study Demonstrates Sustained Improvement in Chronic Low Back Pain Symptoms and Quality of Life|
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 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(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 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.
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.