MiDAS I Clinical Study Results Demonstrate Significant Improvement In Patients Treated With Mild(R)

Main Category: Neurology / Neuroscience
Article Date: 26 May 2010 - 1:00 PDT


Medical device company Vertos Medical, Inc. has announced the release of additional patient outcomes data from the MiDAS I1 (mild Decompression Alternative to open Surgery) trial, a prospective, 75-patient study of mild* for the treatment of lumbar spinal stenosis (LSS). As presented at the Florida Society of Interventional Pain Physicians (FSIPP) Annual Meeting in Orlando on May 23, investigators found that study participants reported statistically significant improvement in both their physical and mental well-being six weeks following the mild procedure. These findings follow the March 2010 release of the initial MiDAS I six-week safety and efficacy data, which were also positive.

The widely used SF12-v2® Quality of Life Survey and Zurich Claudication Questionnaire were employed to measure relative change in patient symptom severity, mental well-being and physical function as well as overall satisfaction with the results of the intervention. Six weeks following treatment with mild, MiDAS I participants reported an improvement from baseline in overall physical and mental well-being between two and three times the minimally important clinical difference (MID), according to the SF12-v2 Health Survey.2,3 Responses to the Zurich Claudication Questionnaire at six weeks also showed statistically and clinically significant post-treatment improvements in pain and function along with an average satisfaction rating of 2.02 on a scale from 1 to 4, with 1 representing the highest satisfaction level.

"This new outcomes data is a powerful testament to the mild procedure's life-changing potential for LSS patients, for whom we've only been able to offer palliative or open surgical treatment options in the past," said Lora Brown, M.D., a practicing pain physician (Bradenton, Fla.) and MiDAS I investigator who presented the findings at the FSIPP meeting. "Building on the six-week safety and efficacy data released earlier this year, these outcomes continue to demonstrate mild's new and important place in our algorithm for treating LSS."

Peer-reviewed publication of comprehensive MiDAS I study data is anticipated later this year. According to Dr. Brown, an extensive scientific literature review has shown MiDAS I to be the most thorough LSS study submitted for publication in recent years.

About mild

mild is an image-guided procedure used to treat patients with LSS, a condition diagnosed in 1.2 million patients annually in the United States.4 A less invasive alternative to open or endoscopic surgery, mild safely and therapeutically reduces pain and increases mobility while maintaining structural stability.

* Vertos mild is FDA cleared for treating central canal stenosis of the lumbar spine.

1 MiDAS I was previously referred to as the Vertos US IRB I Study.

2 The concept of the minimally important clinical difference (MID) refers to the smallest difference in a score that is considered to be worthwhile or important.

3 Ware JE, Snow KK, Kosinski MK, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center; 1993

4 Derived from the Longitudinal Medicare Database.

Source
Vertos Medical, Inc.

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