Empirical Spine announced that it completed enrollment in the investigational arm of its U.S. investigative device exemption trial studying its LimiFlex therapy for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.
The trial reached its target of 135 LimiFlex patients for the investigational arm ,and Empirical Spine plans to continue enrolling the control arm to reach its target of 160 patients. The pivotal trial is slated to compare outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery.
The study’s endpoint is the rate of overall clinical success at 24 months with the goal of displaying that patients can achieve fusion-equivalent results without receiving TLIF treatment, according to a news release. The company said it will use the trial’s results to form the basis for a pre-market approval application to the FDA.