The LimiFlex™ Dynamic Sagittal Tether™

LimiFlex is intended to provide segmental stabilization following decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. LimiFlex is implanted through a dorsal approach, typically through the same incision used for the surgical decompression.

Ultrahigh molecular weight (UHMW) polyethylene bands loop around the spinous processes.

Ultrahigh molecular weight (UHMW) polyethylene bands loop around the spinous processes.

Dynamic titanium rods designed to increase segmental stiffness and reduce flexion range of motion.

Dynamic titanium rods designed to increase segmental stiffness and reduce flexion range of motion.

Mechanism of Action

Biomechanical studies have demonstrated that in a cadaveric model, LimiFlex restores the range of motion of a destabilized segment and increases segmental stiffness; stabilization in flexion has a corresponding effect on translational stability.¹

Lumbar spine in flexion

Lumbar spine in flexion with LimiFlex™

Surgical Results

LimiFlex is designed to be a Faster, less invasive outpatient procedure

Interim IDE study data (includes unmonitored data, propensity score-matching pending); values are medians

LimiFlex Implantation Procedure

Primarily in Europe, more than 2,000 patients have been treated using LimiFlex for segmental stabilization following surgical decompression.

Lateral x-ray

Anteroposterior x-ray

Biomechanics

The LimiFlex Dynamic Sagittal Tether is designed to resist the separation of two adjacent spinous processes through progressive tensile forces applied by polyethylene straps attached in a loop to a pair of titanium couplers sitting on either side of the spinal midline. Cadaveric biomechanical testing has demonstrated that by resisting spinous process separation, the system reduces segmental flexion and maintains facet engagement, stabilizing the treated segment in flexion. Because flexion and segmental translation are coupled, segmental translation is also stabilized.¹

Cadaveric biomechanical testing has demonstrated that LimiFlex may provide sagittal plane stability to destabilized spinal motion segments by:

  • restoring flexion range of motion

  • increasing high flexibility zone stiffness

  • controlling sagittal translation

  • promoting facet joint engagement in flexion

Footnotes

  1. Fielding et al. Eur Spine J 2013;22(12)2710-8.