ALISO VIEJO, Calif., Feb. 26, 2019 /PRNewswire/ — Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), announced today that it received CE mark approval for its mild® device kit. This certification signifies that Vertos has conformed to patient and user safety and device performance standards for the mild device kit and procedure to be marketed and sold in the 32 countries of the European Economic Area.
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.
“Receiving the CE mark is an important step for the company to be able to offer the mild procedure outside of the United States,” said Eric Wichems, President and CEO of Vertos Medical. “We are excited about the prospect of helping European patients who suffer from LSS to stand longer and walk farther with less pain.”
The mild procedure, which received broad coverage from CMS in 2016, has been performed on more than 20,000 patients, and its safety and efficacy have been demonstrated in more than 13 clinical studies and 20 publications. Study data show clinically meaningful and statistically significant mobility improvement and pain reduction, with no serious procedure complications in any clinical trial.1,2
For more information about Vertos Medical, 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-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/.
SOURCE Vertos Medical Inc.