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Providence Medical Technology received FDA 510(k) clearance to market the CAVUX® Facet Fixation System (FFS) for a new indication. The system is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to provide stabilization until fusion occurs.
CAVUX FFS is now indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. CAVUX FFS is now specifically cleared as an adjunct to posterior cervical fusion for anterior cervical fusion revision surgery, a follow-up procedure after an initial surgery failed to resolve symptoms or properly heal.
The FDA clearance was based on results from the Providence-sponsored REVISE Clinical Study, which summarized Real World Evidence pooled across six clinical sites treating patients with CAVUX FFS to revise a prior Anterior Cervical Discectomy & Fusion (ACDF). The dataset consisted of 191 cases reviewed, with half of the patients returning for radiographic and clinical assessments.
Long-term outcomes were collected over an average of 39 months from revision. In the cohort of single-level pseudarthrosis patients returning for follow-up, 96% were determined by the surgeon to be fused and none required a subsequent surgical intervention. Additionally, an independent core lab reported that 92% had a segmental range of motion less than 2 degrees and 75% had continuous bridging bone verified by CT scan. CAVUX FFS is implanted using the company’s flagship CORUS™ Spinal System, which enables a surgeon to perform a tissue-sparing posterior cervical fusion before placing implants.
Providence Medical Technology received FDA 510(k) clearance to market the CAVUX® Facet Fixation System (FFS) for a new indication. The system is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to provide stabilization until fusion occurs.
CAVUX FFS is now indicated for patients requiring a revision...
Providence Medical Technology received FDA 510(k) clearance to market the CAVUX® Facet Fixation System (FFS) for a new indication. The system is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to provide stabilization until fusion occurs.
CAVUX FFS is now indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. CAVUX FFS is now specifically cleared as an adjunct to posterior cervical fusion for anterior cervical fusion revision surgery, a follow-up procedure after an initial surgery failed to resolve symptoms or properly heal.
The FDA clearance was based on results from the Providence-sponsored REVISE Clinical Study, which summarized Real World Evidence pooled across six clinical sites treating patients with CAVUX FFS to revise a prior Anterior Cervical Discectomy & Fusion (ACDF). The dataset consisted of 191 cases reviewed, with half of the patients returning for radiographic and clinical assessments.
Long-term outcomes were collected over an average of 39 months from revision. In the cohort of single-level pseudarthrosis patients returning for follow-up, 96% were determined by the surgeon to be fused and none required a subsequent surgical intervention. Additionally, an independent core lab reported that 92% had a segmental range of motion less than 2 degrees and 75% had continuous bridging bone verified by CT scan. CAVUX FFS is implanted using the company’s flagship CORUS™ Spinal System, which enables a surgeon to perform a tissue-sparing posterior cervical fusion before placing implants.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
