Vertos Medical said it has received CE mark approval for its lumbar spinal stenosis (LSS) treatment device kit.
Aliso Viejo, Calif.-based Vertos said its Mild device kit enables a minimally invasive procedure to remove the cause of stenosis through a portal the size of a baby aspirin. The procedure requires no stitches, general anesthesia, implants or overnight hospital stays, the company added.
The Mild spinal decompression procedure received broad coverage from the Centers for Medicare & Medicaid Services (CMS) via the Coverage with Evidence Development Program in 2016.
“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 Vertos Medical president & CEO Eric Wichems in a prepared statement. “We are excited about the prospect of helping European patients who suffer from LSS to stand longer and walk farther with less pain.”
Data from a CMS-approved study published in 2018 demonstrated the long-term safety and efficacy of the Mild procedure at two years after it occurred. Vertos raised $23 million in 2013 and $28 million in 2017 for its Mild treatment.