Healthcare Professionals

LimiFlex™ Paraspinous Tension Band

LimiFlex Implant

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

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

HP13 Flexion with LimiFlex

Lumbar spine in flexion with LimiFlex™

Degenerative Spondylolisthesis

Symptomatic lumbar spinal stenosis (LSS) with degenerative spondylolisthesis (DS) is a debilitating condition and one of the most common indications for spinal fusion, with more than 100,000 patients per year treated surgically in the United States alone.2  The LimiFlex™ Paraspinous Tension Band is being studied as a new treatment alternative for patients receiving decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.

Degenerative spondylolisthesis may present with varying degrees of instability that impact the treatment decision.

Biomechanics

The LimiFlex™ Paraspinous Tension Band 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.
Biomechanical testing was conducted on human cadaver specimens by AG Patwardhan, Loyola University, Chicago.1

Biomechanical testing was conducted on human cadaver specimens by AG Patwardhan, Loyola University, Chicago.1

LimiFlex Implantation Procedure

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

View Surgical Technique Animation

Lateral X-ray

Lateral X-ray

Anteroposterior X-ray

Anteroposterior X-ray

Publications

Journal Article Journal of Spine April 2017 Dynamic Intraspinous Stabilization reduces Spinal Mobility After Bilateral Laminotomy M Guentchev, L Peter, C Preuss, M Sailer, J Tuettenberg
Journal Article Zeitschrift für Orthopädie und Unfallchirurgie August 2015 Vergleich dorsaler Dekompression nicht stabilisiert und dynamisch stabilisiert mit LimiFlex™ [A Comparison of Dorsal Decompression and Dorsal Decompression Combined with the Dynamic Stabilisation Device LimiFlex™] T Jansen, R Bornemann, L Otten, K Sander, D Wirtz, R Pflugmacher
Journal Article The Spine Journal January 2015 Decompression and paraspinous tension band: a novel treatment method for patients with lumbar spinal stenosis and degenerative spondylolisthesis JNA Gibson, B Depreitere, R Pflugmacher, KJ Schnake, LC Fielding, TF Alamin, J Goffin
Podium Presentation Deutsche Gesellschaft für Neurochirurgie (DGNC), Sektionstagung Wirbelsäule 27-28 September 2013, Frankfurt am Main (Germany) Bewegungserhaltende Therapie bei Pseudolisthese und lumbaler Spinalkanalstenose mit LimiFlex. Erste Erfahrungen mit 30 Patienten A Frank, München
Scientific Poster Deutsche Gesellschaft für Neurochirurgie (DGNC), Sektionstagung Wirbelsäule 27-28 September 2013, Frankfurt am Main (Germany) Lumbale Facettengelenkstabilisierung mit dem Limiflexsystem nach postoperativer Zystenbildung – ein Fallbericht JD Müller-Broich, Dormagen
Scientific Poster International Society for the Study of the Lumbar Spine (ISSLS) 13-17 Mai 2013, Scottsdale, AZ (USA) Lumbar Stabilization with a paraspinous tension band device in patients with degenerative spondylolisthesis and spinal stenosis: 24-month data JNA Gibson, C Beadle, L Fielding, M Wachna, TF Alamin
Scientific Poster Global Spine Congress 4-6 April 2013, Hong Kong Dorsal Decompression with and without Limiflex Stabilization: Prospective Evaluation of 12 Month Results R Pflugmacher, TR Jansen, R Bornemann, K Kabir, DC Wirtz
Scientific Poster InternationalSociety for the Advancement of Spine Surgery (ISASS) 3-5 April 2013, Vancouver (Canada) Dorsal Decompression with and without Limiflex Stabilization: Prospective Evaluation of 12 Month Results R Pflugmacher, TR Jansen, R Bornemann, K Kabir, DC Wirtz
Podium presentation Deutsche Wirbelsäulengesellschaft (DWG) 6-8 December 2012, Stuttgart (Germany) Prospektiver Vergleich von dorsalen Dekompressionen und dorsalen Dekompressionen mit posteriorer dynamischer flexions-begrenzender Stabilisierung bei Patienten mit Spinalkanalstenose und degenerativer Bandscheibenerkrankung: Ein Vergleich der 12-Monats-Ergebnisse TR Jansen, R Bornemann, LA Otten, K Kabir, DC Wirtz, R Pflugmacher
Scientific Poster Norddeutsche Orthopäden- und Unfallchirurgenvereinigung (NOUV) 14-16 June, 2012, Hamburg (Germany) Prospektive Evaluation von dorsalen Dekompressionen mit posteriorer dynamischer flexions-begrenzender Stabilisierung bei Patienten mit Spinalkanalstenose und degenerativer Bandscheibenerkrankung: 12-Monats-Nachuntersuchungen TR Jansen, R Bornemann, LA Otten, K Kabir, JD Müller-Broich, DC Wirtz, R Pflugmacher
Podium presentation World Society for Endoscopic, Navigated & Minimal Invasive Spine Surgery (WENMISS) 5-7 May, 2011, Bonn (Germany) Dynamic flexion-limiting stabilization in patients with spinal stenosis and degenerative disc disease – Six month follow-up T Randau, R Bornemann, DC Wirtz, R Pflugmacher
Scientific Poster Spine Arthroplasty Society (SAS) 26-29 April 2011, Las Vegas (USA) Prospective Evaluation of dorsal decompression and posterior dynamic flexion-limiting stabilization in patients with spinal stenosis and degenerative disc disease: Six month follow up R Pflugmacher, T Randau, K Kabir, R Bornemann, DC Wirtz
Scientific Poster Global Spine Congress 23-26 March 2011, Barcelona (Spain) Prospective evaluation of dorsal decompression and posterior dynamic flexion-limiting stabilization in patients with spinal stenosis and degenerative disc disease: Six month follow up T Randau, DC Wirtz, R Pflugmacher
Scientific Poster British Association of Spinal Surgery (BASS) 2-4 February 2011, Edinburgh (GB) Decompression and posterior dynamic flexion-restricting stabilisation in patients with degenerative spondylolisthesis JNA Gibson, C Beadle, I Ahmed

Biomechanical and Pre-Clinical Publications

Journal article The Spine Journal 15: 2544-51 December 2015 Sacral spinous processes: a morphologic classification and biomechanical characterization of strength T Wang, LC Fielding, A Parikh, M Kothari, TF Alamin
Journal article SPINE 39: E74-E81 January 2014 Compressive preload reduces segmental flexion instability after progressive destabilization of the lumbar spine RW Fry, TF Alamin, LI Voronov, LC Fielding, AJ Ghanayem, A Parikh, G Carandang, BW Mcintosh, RM Havey, AG Patwardhan
Journal article European Spine Journal 22: 2710-2718 December 2013 Parametric and cadaveric models of lumbar flexion instability and flexion restricting dynamic stabilization system LC Fielding, TF Alamin, LI Voronov, G Carandang, RM Havey, AG Patwardhan
Scientific Poster International Society for the Study of the Lumbar Spine (ISSLS) 13-17 Mai 2013, Scottsdale, AZ (USA) In vivo response to a paraspinous tension band device with titanium coil. An ovine implantation study EJ Ehrhart, L Fielding, AL Santoni, BG Santoni, CM Puttlitz, DR Ruehlman, HB Seim III, AS  Turner
Scientific Poster Orthopaedic Research Society (ORS) 26-29 January 2013, San Antonio, TX (USA) Radiographic assessment and biomechanical experiment: Morphology and strength of S1 Spinous process LC Fielding, P Newman, N Wharton, J Buckley, L Cheng, A Parikh, TF Alamin
Journal Article Journal of Neurosurgery. Spine 17: 69-73 July 2012 Failure strength of lumbar spinous processes loaded in a tension band model SR Golish, L Fielding, V Agarwal, J Buckley, TF Alamin
Scientific Poster 5th UHMWPE International Meeting 22-23 Feb 2011, Philadelphia, PA (USA) LimiFlex Wear Evaluation R Siskey, L Fielding, A Parikh, S Kurtz
CAUTION – The LimiFlex Paraspinous Tension Band is an investigational device. Limited by United States law to investigational use.

Reference

1. Fielding et al. Eur Spine J 2013;22(12)2710-8.
2. 1. H-CUPnet National and regional estimates on hospital use for all patients from the HCUP National (Nationwide) Inpatient Sample (NIS). US Department of Health & Human Services.

CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.