ALISO VIEJO, Calif., Oct. 1, 2018 /PRNewswire/ -- Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), today announced the enrollment of the first patient into its nationwide, multicenter study of its mild® procedure. The novel, prospective, randomized controlled study will use clinically validated, patient-reported outcome measures to identify improvements in pain and function, and will capture objective measures of participants' activity levels using Fitbit activity trackers.
The mild procedure is a clinically proven outpatient LSS treatment that removes the cause of stenosis through a portal the size of a baby aspirin. It requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.
The two-year MOTION Study will enroll patients 50-80 years of age and will provide important data to help physicians and patients make early treatment decisions for LSS sufferers. The first MOTION Study patient was enrolled at Michigan Interventional Pain Center in Brownstown, Michigan by Razmig Haladjian, MD, an interventional pain specialist.
"A major step forward in interventional pain occurred with the first patient enrolled in the MOTION Study, a level 1, prospective, randomized, multicenter study that evaluates subjective and objective functional measures," said Dr. Tim Deer, an interventional pain specialist, president and CEO of The Spine and Nerve Center of the Virginias and national principal investigator for the MOTION Study. "This important, activity-based study will generate evidence that further supports minimally invasive LSS treatments to improve patients' quality of life and reduce the use of opioids," added Dr. Deer.
The mild procedure has been performed on more than 20,000 patients and its safety and efficacy have been analyzed in more than 13 clinical studies and 20 publications. Study data has shown clinically meaningful and statistically significant mobility improvement and pain reduction, with no serious device- or procedure-related complications in any clinical trial.
"We are proud to continue to add meaningful data to our extensive body of evidence on the mild procedure," said Eric Wichems, president and CEO of Vertos Medical. "The MOTION Study will provide powerful real-world, quality-of-life data that will help patients and health care providers make informed decisions on the mild procedure as an early treatment choice."
For more information about Vertos Medical, or the MOTION Study, please visit www.vertosmed.com.
Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include the mild® instrumentation kit, which enables 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. The mild procedure 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 the mild procedure can help LSS patients stand longer and walk farther with less pain.1 No major device- or procedure-related complications have been reported in any clinical trial.2 Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how the mild procedure treats LSS, go to www.vertosmed.com/products/.
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SOURCE Vertos Medical Inc.