Paradigm Spine announces publication of long-term coflex results


Hyun Bae et al’s study, “Therapeutic sustainability and durability of coflex Interlaminar Stabilization after decompression for lumbar spinal stenosis: a four year assessment” has been published in the International Journal of Spine Surgery.

According to a company press release, “The data demonstrate the long-term sustained therapeutic effect of Paradigm Spine’s coflex Interlaminar Stabilization for patients with lumbar spinal stenosis.” With 344 patients enrolled and randomised in this study, and a high follow-up rate of over 85% at four years in both treatment groups, the authors concluded, “This study demonstrates that coflex Interlaminar Stabilization is associated with improved clinical, safety, and radiographic outcomes at 48 months post-op when compared to fusion in the studied patient population.”


Success rate, comprised of no second intervention and an Oswestry Disability Index (ODI) improvement of ≥15 points, was 57.6% of interlaminar stabilisation and 46.7% of fusion patients (p=0.095). Adding lack of fusion in the interlaminar stabilisation cohort and successful fusion in the fusion cohort showed a composite clinical success rate of 42.7% and 33.3%, respectively. Adding adjacent level success to both cohorts and maintenance of foraminal height in the coflex cohort showed a success rate of 36.6% and 25.6%, respectively. “With additional follow-up to five years in the US pre-market approval study, these trends are expected to continue to show the superior therapeutic sustainability of interlaminar stabilisation compared to posterolateral fusion after decompression for spinal stenosis,” write the authors.

Hallett Mathews, executive vice president and chief medical officer of Paradigm Spine has confidence that both patients and surgeons will be positively impressed with the long-term durability and sustainability provided with the coflex device.  “Surgeons appreciate the effectiveness of providing stabilisation after decompression for advanced degenerative lumbar spinal stenosis.  The long-term results discussed in this article provide Level 1 evidence that fusion stabilisation may no longer be the gold standard for spinal stenosis patients. We anticipate that the payor community will embrace these findings as further evidence of comparative effectiveness of coflex Interlaminar Stabilization in providing durable and sustained therapeutic benefits for spinal stenosis patients, when compared with fusion.”