Paradigm Spine receives first US private payer coverage for Coflex

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Paradigm spine logoThe Blue Cross Blue Shield of Michigan has issued a coverage policy in favour of interlaminar stabilisation devices.

Titled “Interspinous/Interlaminar Stabilization/Distraction Devices (Spacers),” the policy is dated September 1, 2017. Paradigm Spine’s Coflex is currently the only product that has achieved US Food and Drug Administration (FDA) pre-market approval (PMA) approval for up to a Grade I spondylolisthesis.

Unlike traditional surgical treatment options, the Coflex device is a non-fusion, motion-preserving stabilisation implant. It can be used in conjunction with a decompression or used in lieu of a spinal fusion.

Matthew Songer assistant professor, College of Human Medicine, Michigan State University, East Lansing, USA, says, “Over the last four years, I have treated 80 patients with Coflex. In comparison to fusion, [the device] is less invasive, requires a short hospital stay, allows for a much quicker recovery with return-to-work time in as little as two weeks.  In comparison to decompression-alone, Coflex adds durability to already good outcomes, while maintaining the fast recovery.  I am delighted insurance coverage will now be available to more of my patients.”

Long-term results

Five-year Level 1 data published last year demonstrates positive results for the device in lumbar spinal stenosis patients. The results showed the long-term sustained therapeutic effect of Coflex in comparison to fusion. Published in the International Journal of Spine Surgery, the data had a 90% follow-up rate among 322 enrolled patients.

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