LimiFlex™ Paraspinous Tension Band

LimiFlex-Implant.550

Mechanism of Action

LimiFlex™ restores the range of motion of a destabilized segment and increases segmental stiffness, as demonstrated in biomechanical testing. Stabilization in flexion has a corresponding effect on translational stability.

Lumbar spine in flexion.

Lumbar spine in flexion
 
 
 
 

HP13 Flexion with LimiFlex

Lumbar spine in flexion with LimiFlex™ stabilizing the treated segment L4-L5 in flexion and translation: The yellow outlines show the hypothetical position of the vertebra without stabilization measures as illustrated on the image on the left

Mechanism of Action: Video by Todd F. Alamin, MD.1

Primary Indications

LimiFlex™ is primarily used in the treatment of lumbar spinal stenosis, with or without degenerative spondylolisthesis, after surgical decompression.

Primary Indications: Video by Todd F. Alamin, MD.1

LimiFlex™ is implanted through a dorsal approach, typically through the same incision used for the surgical decompression, without requiring placement of bone-penetrating screws. Small, controlled pre-tension is applied to the device when the segment is in the neutral position. This allows the benefits of surgical decompression to be maintained and ensures that the facets are not locked or overloaded.

System Values

LimiFlex™ provides segmental stability without compromising spinal function. It is quick and easy to implant, and results in sustained improvements in function and pain.2 Compared to some alternative treatment options it has the following potential benefits:
• Typical 15 minute implantation time2
• Reduced overall procedure time compared with pedicle screw based fixation systems2,3
• One size: Band locking mechanism allows adjustment to patient size and anatomy2,3
• Band fixation results in less procedural morbidity compared to pedicel screw fixation2,4,5
• LimiFlex™ works in parallel with ligaments and facets, and utilizes low forces to minimize loads on the anatomy6
• Maintains lordosis and promotes sagittal balance while preventing progressive slip and translation2

Safety Information

There are risks associated with all surgical procedures. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please refer to the instructions for use.

Reference

1. Todd F. Alamin, MD, orthopedic spine surgeon at Stanford University School of Medicine and co-founder of Simpirica Spine
2. Simpirica Spine Post Market Clinical Study; data on file
3. Weinstein JN et al. N Engl J Med 2007;356:2257–70
4. Yuan HA et al. Spine 1994;19(20S):2279S–96S
5. Deyo RA et al. JAMA 2010;303:1359–65
6. Fielding LC et al. Eur Spine J 2013;22:2710-2718