Empirical Spine completed enrollment in the investigational arm of its U.S. Investigational Device Exemption trial of the LimiFlex Paraspinous Tension Band with decompression to treat degenerative spondylolisthesis with lumbar spinal stenosis.
The trial compares outcomes of patients who receive either LimiFlex, pictured above, or transforaminal lumbar interbody fusion following a decompression procedure. The target of 135 LimiFlex patients are enrolled in the investigational arm. The control arm will continue enrolling to its target of 160 patients. Trial results will support submission of a Premarket Approval application to FDA.
LimiFlex was developed as a motion-preserving alternative to use of instrumentation and bone graft to stabilize the spine, post-decompression. The prospective, multi-center, controlled clinical trial will evaluate safety and efficacy of the device compared to fusion, with a goal of showing that patients can achieve fusion-equivalent results, without the fusion.
The device received approval under the CE Mark in 2009 and has been implanted in over 2,000 patients in Europe.
Co-primary trial investigator Rick Sasso, M.D. said, "My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilize the spine yet preserve motion. Many patients are extremely interested in less invasive stabilization options that avoid the complications of fusion, so they are attracted to LimiFlex. The device is easy to implant and has demonstrated great results in Europe, which we expect to confirm in this U.S.-based study.