Sam Brusco, Associate Editor01.10.24
Providence Medical Technology has gained U.S. Food and Drug Administration (FDA) clearance for its CAVUX FFS-LX lumbar facet fusion system for lumbar spinal fusion surgery.
The integrated cage is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD). It spans the facet interspace with fixation points at each end of the construct for additional stabilization for 1- or 2-level lumbar interbody fusion.
FFS-LX can be used without pedicle screws and rods, and is inserted using the company’s CORUS spinal system-LX tissue-sparing access and spinal fusion system.
Providence said CAVUX FFS-LX was designed to offer more stabilization after lumbar fusion to increase fusion rates and minimize future complications and reoperations.
Clinical study data reported 57 patients with a median follow-up of 30 months. Median age was 45, median body mass index was 30, and 68% of subjects reported nicotine use as a risk factor.
96% of levels were determine to be fused as defined by range of motion less than five degrees on flexion/extension x-rays. 79% of subjects achieved clinically meaningful pain improvement.
"At Providence, we are driven to improve clinical outcomes and prevent surgical failures for high-risk patients," commented Jeff Smith, co-founder and CEO of Providence Medical Technology. "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."
The integrated cage is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD). It spans the facet interspace with fixation points at each end of the construct for additional stabilization for 1- or 2-level lumbar interbody fusion.
FFS-LX can be used without pedicle screws and rods, and is inserted using the company’s CORUS spinal system-LX tissue-sparing access and spinal fusion system.
Providence said CAVUX FFS-LX was designed to offer more stabilization after lumbar fusion to increase fusion rates and minimize future complications and reoperations.
Clinical study data reported 57 patients with a median follow-up of 30 months. Median age was 45, median body mass index was 30, and 68% of subjects reported nicotine use as a risk factor.
96% of levels were determine to be fused as defined by range of motion less than five degrees on flexion/extension x-rays. 79% of subjects achieved clinically meaningful pain improvement.
"At Providence, we are driven to improve clinical outcomes and prevent surgical failures for high-risk patients," commented Jeff Smith, co-founder and CEO of Providence Medical Technology. "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."