Providence Medical Technology has received US Food and Drug Administration (FDA) clearance for its CAVUX FFS-LX Lumbar Facet Fixation System, designed for lumbar spinal fusion surgery.
CAVUX FFS-LX is an integrated cage and screw system that can be implanted bilaterally in the facet joints for the treatment of lumbar degenerative disc disease (DDD).
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The implant spans the facet interspace with fixation points at each end of the construct. This offers additional stabilisation for 1 or 2-level lumbar interbody fusion.
It can be used with or without pedicle screws and rods and implanted using Providence Medical’s CORUS Spinal System-LX tissue-sparing access and spinal fusion system.
Providence Medical Technology co-founder and CEO Jeff Smith said: “At Providence, we are driven to improve clinical outcomes and prevent surgical failures for high-risk patients.
“CAVUX FFS-LX builds off our successful cervical platform and applies the same principles to the lumbar spine where the challenge of treating high-risk patients is even more pronounced. We are excited to be launching into the lumbar market and provide high-risk patients a new option for a fusion success.”
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By GlobalDataThe approval was supported by data from a clinical study, which evaluated the system in 57 patients with a median follow-up of 30 months, revealing a 96% fusion rate as verified by an independent core imaging lab.
In the study, 79% of the subjects reported clinically meaningful improvement in pain.
Washington Spine and Scoliosis Institute founder Joseph O’Brien said: “I am excited about the FDA clearance of CAVUX FFS-LX as a treatment option for patients treated with lumbar fusion for degenerative disc disease.
“The implant provides increased stabilisation at the lumbar facet level for minimally invasive fusion procedures. This new option will expand the spine specialist’s treatment arsenal and likely lead to increased fusion rates for patients. I have seen excellent results from this technology in challenging fusion patients.”
