Clinical review of minimally invasive IDET procedure demonstrates significant decrease in lower back pain

Meta-Analysis of 17 Published Studies Proves Procedure Effective and Safe

ANDOVER, Mass., August 16, 2006 ─ A meta-analysis of the Intradiscal ELECTROTHERMAL◊ Therapy (IDET◊) 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◊ 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.

About Smith & Nephew

Smith & Nephew is a global medical technology business, specializing in Endoscopy, Orthopaedic Reconstruction, Orthopaedic Trauma 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 in excess of $2.6 billion.

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Joe Metzger
Smith & Nephew Endoscopy

Gena Henderson