First built-in aspect screw and cage system cleared by the FDA to revise a failed ACDF.
PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/ — Windfall Medical Expertise, Inc., a medical machine innovator centered on enhancing surgical outcomes for high-risk spine surgical procedure sufferers, introduced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® Aspect Fixation System (FFS) for a brand new indication. The Aspect Fixation System (FFS) is a novel built-in cage and screw system that’s implanted bilaterally within the aspect joints to supply stabilization till fusion happens.
CAVUX FFS is now “indicated for sufferers requiring a revision for an anterior pseudarthrosis at one degree, from C3 to C7, with autogenous and/or allogenic bone graft.” The clearance represents a big milestone. CAVUX FFS is now particularly cleared as an adjunct to posterior cervical fusion for anterior cervical fusion revision surgical procedure, a follow-up process after an preliminary surgical procedure didn’t resolve signs or correctly heal.
The FDA clearance was based mostly on outcomes from the Windfall-sponsored REVISE Scientific Research. The examine summarized Actual World Proof pooled throughout six medical websites treating sufferers with CAVUX FFS to revise a previous Anterior Cervical Discectomy & Fusion (ACDF). The dataset consisted of 191 instances reviewed, with half of the sufferers returning for radiographic and medical assessments. Lengthy-term outcomes had been collected over a mean of 39 months from revision. Within the cohort of single-level pseudarthrosis sufferers returning for follow-up, 96% had been decided by the surgeon to be fused and none required a subsequent surgical intervention. Moreover, an unbiased core lab reported that 92% had a segmental vary of movement lower than 2 levels and 75% had steady bridging bone verified by CT scan (CAT scan). CAVUX FFS is implanted utilizing the corporate’s flagship CORUS™ Spinal System, which permits a surgeon to carry out a tissue-sparing posterior cervical fusion earlier than putting implants.
Windfall CEO & Co-founder Jeff Smith commented, “At Windfall, our objective is enhancing medical outcomes and stopping surgical failures for high-risk spinal fusion sufferers. CORUS Spinal System, indicated for cervical and lumbar fusion, is the worldwide market chief in tissue-sparing posterior spinal fusion. CAVUX FFS delivers highly effective stabilization via its distinctive built-in cage and screw design. CAVUX FFS is indicated as an adjunct to PCF with CORUS Spinal System and supplies non-segmental instrumentation via a novel design that spans the aspect joint interspaces with factors of fixation at each ends of the assemble.”
“We’re grateful to our staff of Investigators and affected person volunteers who performed the long-term follow-up research demonstrating the protection and effectiveness of CAVUX FFS for revision surgical procedure. Excessive-risk spinal fusion sufferers endure nonunion charges as excessive as 50% and require revision surgical procedure. We’re inspired by the favorable medical outcomes of REVISE and excited CAVUX FFS is now indicated for revision surgical procedure.”
Dr. Michael M. Haglund, Endowed Professor of Neurosurgery and Orthopaedic Surgical procedure at Duke College and lead investigator of the REVISE examine, commented, “I focus on cervical spine surgical procedure and my most well-liked strategy to a failed ACDF is a posterior cervical fusion with the CORUS Spinal System and CAVUX FFS. The tissue-sparing strategy permits me to stabilize and fuse posteriorly with out the morbidity related to lateral mass screws and the normal posterior strategy. My sufferers tolerate this process significantly better than the alternate options. I’ve carried out this process on nearly 100 sufferers and am excited to have the ability to exhibit the advantages via this examine.”
The CORUS Spinal System is indicated for posterior cervical fusion and has been utilized in over 16,000 instances worldwide. Over 40,000 CAVUX implants have been implanted since 2013.
For extra info, together with full indications and security info, please go to providencemt.com/cavux-ffs.
About Windfall Medical Expertise, Inc.
Windfall Medical Expertise, Inc. is a privately held medical machine firm centered on modern and tissue-sparing surgical options for cervical spine surgical procedure. Its objective is to enhance medical outcomes for high-risk sufferers and stop surgical failures of the cervical spine. Its mission is to determine Circumferential Cervical Fusion (CCF) as the usual of look after high-risk sufferers. The Firm has pioneered a proprietary strategy to posterior cervical fusion and has developed surgical instrumentation and implants that tackle the unmet medical want of and provide distinctive advantages to the $2 billion worldwide cervical spine market.
The Windfall household of merchandise contains the CORUS™ Spinal System, CAVUX® intervertebral implants, ALLY® bone and aspect screws, and ENTRUS™ Allograft Bone. All implants and devices are sterile-packaged and single-use to maximise perioperative effectivity and guarantee constant high quality and efficiency.
SOURCE Windfall Medical Expertise
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