Vertos Medical Completes Enrollment in Back Pain Treatment Study

Vertos Medical Inc. has completed enrollment for a new 27-site study comparing two conservative treatments for back pain resulting from lumbar spinal stenosis in patients with neurogenic claudication.

The company reported that 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)—the company’s technology—or epidural steroid injections. The study is part of the Coverage with Evidence Development status granted by Centers for Medicare and Medicaid Services 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 the 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 Ramsin Benyamin, M.D., a study principal investigator and president of the American Society of Interventional Pain Physicians. “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.”

According to Peter Staats, M.D., a study principal investigator and secretary of the American Society of Interventional Pain Physicians, there have been more than 20,000 patients treated with MILD.

“Given the low cost of the procedure, this therapy could provide significant benefits to the healthcare system,” Staats said. “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.

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 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 the condition by restoring space in the spinal canal using specialized devices to remove hypertrophic ligamentum flavum through a 5.1 millimeter treatment portal. The Mild device kit has been cleared by the U.S. Food and Drug Administration for decompression of the lumbar spine.

Vertos Medical headquarters, physician training and device manufacturing facility is located in Aliso Viejo, Calif.