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.
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...
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.
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