The investigational arm of Empirical Spine's IDE clinical trial completed enrollment Dec. 4 for its study of the LimiFlex Paraspinous Tension Band.
Four insights:
1. LimiFlex is designed to stabilize the spine as an alternative to spinal fusion and is implanted following a decompression surgery.
2. The clinical trial is studying the use of LimiFlex in patients undergoing a decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.
3. LimiFlex has been implanted in more than 2,000 patients in Europe since it received the CE mark in 2009.
4. The trial's investigational arm enrolled 135 patients and the control arm will continue enrolling until it reaches 160 participants.