16.08.2006 14:37:00
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Clinical Review of Minimally Invasive IDET(TM) Procedure Demonstrates Significant Decrease in Lower Back Pain
ANDOVER, Mass., Aug. 16 /PRNewswire-FirstCall/ -- A meta-analysis of the Intradiscal ELECTROTHERMAL(TM) Therapy (IDET(TM)) procedure examining outcomes of 17 clinical studies demonstrates that patients suffering from chronic disc-related low back pain experience a significant decrease in pain and improvement in physical function, as well as a low incidence of complications. The study is published in the July/August issue of Pain Medicine, the peer-reviewed journal of the American Academy of Pain Medicine.
Study authors Dr. Gunnar B.J. Andersson, professor and chairman of orthopedic surgery, Rush-Presbyterian-St. Luke's Medical Center, Chicago, and Dr. Michael Totta, physiatrist of the Spine Center at Orthopedic Associates of Portland in Portland, Maine, systematically synthesized all peer-reviewed published literature describing outcomes following the IDET procedure involving more than 500 patients. The majority of clinical studies reported outcomes assessed from six to 24-months post-treatment.
"The collective study results provide compelling evidence that the IDET procedure can significantly improve the quality of life for patients who suffer from chronic disc-related low back pain and are seeking relief," said Dr. Andersson.
Meta-Analysis Results of IDET Procedure
Meta-analytic techniques applied to measurement tools, such as the Visual Analog Scale (VAS) and Bodily Pain (BP) and Physical Functioning (PF) subscales of the SF-36 and the Oswestry Disability Index (ODI), were used to examine the overall treatment effects of the IDET procedure. The most frequently reported efficacy outcomes were the improvements in the VAS assessment of pain, and the BP and the PF subscales of the SF-36 health survey and ODI. The safety of the IDET procedure was evaluated by pooling the incidence of complications among the published literature.
Based on the meta-analysis, the review concludes that a statistically significant decrease in pain is reported post-treatment. These authors found a mean improvement of 2.9 points on the VAS and a mean improvement of 21 points on the BP subscale of the SF 36. Statistically significant improvements in physical function were also recorded. These improvements following the IDET procedure were accompanied by a low incidence of complications.
"By gathering the results from all the studies on the IDET procedure, we have reinforced that the entire body of evidence supports the effectiveness of the procedure," said Dr. Totta. "A meta-analysis is a statistical method that combines the results of several independent clinical trials. By integrating the body of evidence for a procedure, a meta-analysis allows for a more objective appraisal of the data and can also contribute to considerations about the consistency of the study results."
About the IDET Procedure
Intradiscal ELECTROTHERMAL(TM) Therapy (IDET) is a minimally invasive outpatient surgical procedure for patients suffering from chronic disc-related lower back pain who have failed a program of aggressive non-operative therapy. During the procedure, controlled levels of thermal heat are applied directly to the affected disc. The heat contracts and thickens the collagen fibers within the disc wall, cauterizing the tiny nerve endings that cause the pain and potentially closing the cracks and tears.
The IDET procedure can be performed in less than one hour, is safe and has a low incidence of complications. Since 1998, over 60 peer-reviewed articles have been published on the IDET procedure supporting the procedure's efficacy and safety.
For more information about the IDET procedure, please visit http://www.idetprocedure.com/.
About Smith & Nephew
Smith & Nephew (http://www.smith-nephew.com/) is a global medical technology business, specializing in Endoscopy, Orthopaedic Reconstruction, Orthopaedic Trauma and Clinical Therapies, and Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.
Smith & Nephew is dedicated to helping improve people's lives. The company prides itself on the strength of its relationships with its surgeon and professional healthcare customers, with whom its name is synonymous with the highest standards of performance, innovation and trust. The company has more than 8,500 employees and operates in 33 countries around the world and generated sales of nearly $2.6 billion.
Forward Looking Statements
This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. In particular, statements regarding expected revenue growth and operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation, claims and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.
All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Smith & Nephew's Intradiscal ELECTROTHERMAL(TM) Therapy (IDET(TM)) is a trademark of Smith & Nephew, registered U.S. Patent & Trademark Office.
Joe Metzger Gena Henderson Smith & Nephew Endoscopy MS&L 978-749-1330 617-937-2584 joe.metzger@smith-nephew.com gena.henderson@mslpr.com
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