Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has 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.
Source: Company Press Release