Empirical Spine completed enrollment in its prospective, multi-center, controlled clinical U.S. Investigational Device Exemption trial studying the use of the LimiFlex Paraspinous Tension Band with a decompression to treat degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients receiving either LimiFlex or transforaminal lumbar interbody fusion after decompression.
The trial reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial in December 2019, and the control arm has achieved its target of 160 patients. To date, 168 study subjects have reached 12 month follow-up. Results will form the basis for a premarket approval application to FDA, anticipated by the end of 2021.
The study endpoint is the rate of overall clinical success at 24 months. The goal is to show that patients can achieve fusion-equivalent results, without fusion.
The LimiFlex device received CE Mark approval in 2009 and has been implanted in over 2,000 European patients.