activL®

Lumbar disc prosthesis

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activ L

activL® is the lumbar disc prosthesis for the motion preserving treatment of degenerative disc disease of the lumbar spine. The main objectives of the treatment are fast pain reduction and the preservation/restoration of segmental function and motion. The specific design of activL® allows the protection of the adjacent level. The uniplanar translational movement of activL® is designed to minimize biomechanical stress at the facet joints and to avoid facet joint arthrosis in a medium- and long-term prospect.

Advantages

  • Unique translational movement to avoid biomechanical stress at the facet joint
  • Unique translational movement for an effective protection of the adjacent disc levels
  • Anterior and antero-lateral approach possible
  • Specific instrumentation for the antero-lateral approach
  • Design of prosthesis plates adapted to the anatomy of vertebral body endplates
  • Specific prosthesis design treatment of L5-S1
  • Plasmapore® coating for a fast and safe bony integration of the prosthesis plates to the vertebral body endplates
  • Spikes and/or Keels as primary stability structures. Can be used together in any combination.

Features

  • Unique translational movement
  • Convex prosthesis plates
  • Anatomical adapted footprint
  • Differentiated implant design for L5-S1
  • Spikes and/or Keel
  • Plamapore® coating
  • Specific PE material for the Inlay
  • Smallest height with 8.5 mm
  • Instrumentation for the lateral approach
  • Free choice of direction of approach (angulation)
  • Revision instruments

Indication

Motion preserving total disc replacement (TDR)/disc arthroplasty in case of:

  • Degenerative Disc Disease (DDD) with leg and/or back pain and/or neurological deficits in legs and/or feet with or without disc herniation.
  • Lumbar discopathy and / or black disc syndrome.
    Monosegmental or bisegmental disc degeneration between L3-S1.
  • Without significant degeneration of the facet joints.
  • Without significant instability.
  • Preoperative disc height of at least 3-4 mm.

Scientific Studies

  • Biotribological evaluation of artificial disc arthroplasty devices: Influence of loading and kinematic patterns during in vitro wear simulation; Thomas M. Grupp, James J. Yue, Rolando Garcia Jr., Janet Basson, Jens Schwiesau, Bernhard Fritz, Wilhelm Blömer; Eur Spine J (2009) 18:98-108
  • Analysis of Spinal Kinematics Following Implantation of Lumbar Spine Disc Prostheses versus Fusion: Radiological Study; A. Nabhan, B. Ishak, A. Al Hary, W. I. Steudel, O. Kollmar, O. Steimer; Journal of Long-Term Eff ects of Medical Implants, 17(3): 107-113 (2007)
  • Lumbar Total Disk Arthroplasty – Design and Technique Considerations for the Next-Generation Implant; James J. Yue, Rolando Garcia; Backup 2-2005, Springer
  • Initial Clinical Results of the activL® Lumbar Total Disc Replacement (TDR) Prosthesis: A Prospective Study with 1 year follow-up; Dirk Brücher, Christof Müller, Rolando Garcia, James J. Yue; Abstract/Poster on SAS 2007
  • Early Clinical and Radiographic Outcome with the activL® Total Disc Replacement: Data from Two Centers in the US IDE Trial; Garcia Rolando, Yue James J.; Abstract/Poster on SAS 2008
  • Clinical Evaluation of a New Lumbar Artificial Disc (activL®); S. Sola, R.Hebecker, S. Mann, J. Piek; Abstract/Poster SAS 2008
  • Prospective Randomized US Trial Comparing an Unconstrained, Semi-constrained, and Constrained TDR in the Treatment of Single Level Discogenic Pain: Radiograhic Results from 2 Centers in an FDA IDE Study; Garcia R., Yue J.J.; Abstract/Oral Presentation SAS 2009
  • Volumetric Analysis of Foraminal Parameters Following Lumbar Total Disc Replacement: A Radiographic and Clinical Comparison of 3 Biomechanical Types of Lumbar Disc Replacements: A Semi-Constrained Device, A Controlled Translation Device (CTD) and An Unconstrained Device; Yue J.J., Garcia R., Morreale J.M.; Abstract/Oral Presentation SAS 2009
  • Intercontinental Differences in Surgeon’s Preferences: North American versus European Surgeon Differences in Choice of Primary Endplate Fixation, Implant Size, Lordosis and Height; Rolando Garcia Jr MD, James Y Yue MD, Wolfgang Daiber; Abstract/Poster SAS 2009

Scientific Evidence

Scientific Evidence
Five-year Results of Randomized Trial

Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease

Yue, James J. MD; Garcia, Rolando MD, MPH†; Blumenthal, Scott MD; Coric, Dom MD; Patel, Vikas V. MD; Dinh, Dzung H. MD; Buttermann, Glenn R. MD; Deutsch, Harel MD†; Miller, Larry E. PhD; Persaud, Elizabeth J. PhD; Ferko, Nicole C. MSc; SPINE: December 15, 2019 – Volume 44 – Issue 24 – p 1685-1696.

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Progression of Adjacent-level Degeneration after Lumbar Total Disc Replacement

Results of a Post-hoc Analysis of Patients with Available Radiographs from a Prospective Study with 5-year Follow-up

Zigler, Jack E. MD; Blumenthal, Scott L. MD; Guyer, Richard D. MD; Ohnmeiss, Donna D. Dr.Med; Patel, Leena PhD†; Spine: October 15, 2018 – Volume 43 – Issue 20 – p 1395-1400.

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Video Skydiving activ® L

Lumbar Artifical Disc

Videos

  • Activ L _MM Name_en

    Activ L _MM Descr_en

  • Video Revision activ® L

    Lumbar Artifical Disc

  • Video Standard Features activ® L

    Lumbar Artificial Disc

  • Video L5-S1 Features activ® L

    Lumbar Artifical Disc

  • Video Spike Version Midline Approach activ® L

    Lumbar Artifical Disc

  • Video Spike Version Pararectus Approach activ® L

    Lumbar Artifical Disc

  • Video Keel Version Midline Approach activ® L

    Lumbar Artifical Disc

  • Video activ® L Lateral Approach with activ® O

    Lumbar Artifical Disc and Anterior Lumbar Retractor System