Study Published: Long-Term Results of Level 1 Data for coflex Interlaminar Stabilization vs. Fusion

By Julie A. Vetalice

Study results from 5-year follow-up demonstrate the long-term, sustained therapeutic effect of Paradigm Spine's coflex® Interlaminar Stabilization® (ILS) vs. fusion in the treatment of lumbar spinal stenosis.

The randomized, 21-center study enrolled 322 patients with a follow-up rate of >90% at five years. Use of ILS after decompression produced outcomes similar or superior to fusion with pedicle screws, and one and two levels yield equally good results vs. fusion. Two-level decompression + ILS yielded a significantly lower rate of revision vs. fusion.

The coflex Interlaminar Stabilization® device is supported by >20 years of clinical history, with patients treated in >40 countries.

Sources: Paradigm Spine, LLC;  "Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial," International Journal of Spine Surgery

  • coflex was based on the Interspinous U product from Fixano.
  • In 2006, Paradigm Spine received an Investigational Device Exemption from FDA, allowing Paradigm to begin a 460-patient multi-center clinical trial comparing coflex with pedicle screw fusion.
  • In 2012, FDA granted Premarket Approval for coflex for the treatment of moderate to severe stenosis with or without back pain.

Product Labels: Lumbar Spine, Spinal Fusion

Tags: Trial/Study