Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® Facet Fixation System (FFS) for a new indication. The Facet Fixation System (FFS) 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.” The clearance represents a significant milestone. 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. The study 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 (CAT 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 CEO & Co-founder Jeff Smith commented, “At Providence, our purpose is improving clinical outcomes and preventing surgical failures for high-risk spinal fusion patients. CORUS Spinal System, indicated for cervical and lumbar fusion, is the global market leader in tissue-sparing posterior spinal fusion. CAVUX FFS delivers powerful stabilization through its unique integrated cage and screw design. CAVUX FFS is indicated as an adjunct to PCF with CORUS Spinal System and provides non-segmental instrumentation through a novel design that spans the facet joint interspaces with points of fixation at both ends of the construct.”
“We are grateful to our team of Investigators and patient volunteers who conducted the long-term follow-up studies demonstrating the safety and effectiveness of CAVUX FFS for revision surgery. High-risk spinal fusion patients suffer nonunion rates as high as 50% and require revision surgery. We are encouraged by the favorable clinical results of REVISE and excited CAVUX FFS is now indicated for revision surgery.”
Dr. Michael M. Haglund, Endowed Professor of Neurosurgery and Orthopaedic Surgery at Duke University and lead investigator of the REVISE study, commented, “I specialize in cervical spine surgery and my preferred approach to a failed ACDF is a posterior cervical fusion with the CORUS Spinal System and CAVUX FFS. The tissue-sparing approach allows me to stabilize and fuse posteriorly without the morbidity associated with lateral mass screws and the traditional posterior approach. My patients tolerate this procedure much better than the alternatives. I have performed this procedure on almost 100 patients and am excited to be able to demonstrate the benefits through this study.”
The CORUS Spinal System is indicated for posterior cervical fusion and has been used in over 16,000 cases worldwide. Over 40,000 CAVUX implants have been implanted since 2013.
Source: Company Press Release
