Empirical Spine Completes Portion of Enrollment for LimiFlex Clinical Trial

By Julie A. Vetalice

Empirical Spine LimiFlex
Paraspinous Tension Band

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 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 toward its target of 160 patients. Trial results will support a premarketing approval application to the FDA.

The LimiFlex was developed as a motion-preserving alternative to the use of instrumentation and bone graft to stabilize the spine, post-decompression. The prospective, multi-center, controlled clinical trial will evaluate the 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 European patients.

Product Labels: Dynamic Stabilization

Tags: Trial/Study