National Study Comparing Minimally Invasive Lumbar Decompression (MILD) With Epidural Steroid Injections (ESIs) Reaches Full Enrollment

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Vertos’ MILD Procedure Offers Non-Surgical Option for Lumbar Spinal Stenosis Patients Exhibiting Neurogenic Claudication

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“There have been more than 20,000 patients treated with MILD and given the low cost of the procedure, this therapy could provide significant benefits to the health care system,” said Dr. Peter Staats, a study principal investigator.

A new 27-site study comparing two conservative treatments for back pain resulting from lumbar spinal stenosis in patients with neurogenic claudication has reached full enrollment and all patients have been treated.

The randomized controlled study, MiDAS ENCORE, will examine the long-term benefits for approximately 300 patients who received either minimally invasive lumbar decompression (MILD) or epidural steroid injections (ESIs). The study, which will supplement a robust existing data set on MILD’s efficacy, is part of the Coverage with Evidence Development (CED) status granted by Centers for Medicare & Medicaid Services (CMS) in January 2014.

Lumbar spinal stenosis is primarily a degenerative, age-related narrowing of the lower spinal canal resulting in compression of the nerve roots. MILD treats this compression by removing small portions of lamina and hypertrophic ligamentum flavum in a minimally invasive, outpatient procedure through an opening about the size of a baby aspirin.

“We are pleased that we were able to reach full enrollment and treat all patients so
quickly,” said Dr. Ramsin Benyamin, a study principal investigator and president of the American Society of Interventional Pain Physicians (ASIPP). “We are looking forward to seeing whether the data from this study will confirm the findings from published articles and clinical experience that concluded that MILD was a reasonable and medically necessary treatment for lumbar spinal stenosis.”

“There have been more than 20,000 patients treated with MILD and given the low cost of the procedure, this therapy could provide significant benefits to the health care system,” added Dr. Peter Staats, a study principal investigator and secretary of the American Society of Interventional Pain Physicians. “We hope the data from this study will show that the treatment is safe and effective and can be offered to the many patients who currently lack viable treatment options for their lumbar stenosis symptoms.”

Chronic back pain is the most common health problem in the United States, and a patient has limited interventional pain treatment options prior to progressing to open spine surgery. Lumbar spinal stenosis affects hundreds of thousands every year, primarily those in the Medicare population.

Both principal investigators will be presenting a poster detailing the design, methods and objectives of their multiple-site study at the 2015 American Society of Interventional Pain Physicians Annual Meeting April 9-11.

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Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild® treats this condition by restoring space in the spinal canal using specialized mild® devices to remove hypertrophic ligamentum flavum through a 5.1 mm treatment portal. Clinical studies show that mild® can help LSS patients stand longer and walk farther with less pain1, and no major complications related to the devices or the procedure have been reported.2 Vertos Medical headquarters, physician training and device manufacturing facility is located in Aliso Viejo, CA. To learn more about how mild® treats LSS visit: VertosMed.com

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