PLEASANTON, Calif., July 11, 2024 /PRNewswire/ — Providence Medical Technology announces FDA Clearance of its CORUS™ Posterior Cervical Stabilization System (PCSS) for the treatment of up to 3-level cervical Degenerative Disc Disease (DDD). The FDA clearance was based on results from the FUSE IDE study, a prospective, multicenter, randomized controlled trial comparing safety and effectiveness of Circumferential Cervical Fusion (CCF) versus Anterior Cervical Discectomy and Fusion (ACDF) alone in high-risk cervical fusion patients.
The FUSE Study was performed at 18 U.S. sites across 13 states and enrolled 227 patients aged 18 to 80, with symptomatic cervical DDD at three contiguous levels. The study randomized subjects to receive ACDF, the current standard of care, or CCF (ACDF plus posterior cervical fusion with the company’s PCSS technology). Interim analysis was performed on over 200 subjects at 1 year follow-up and 100 patients at 2 years follow-up.
The interim analysis demonstrated the superiority of CCF in the study’s primary endpoint of fusion success, highlighting the profound benefits of tissue-sparing CCF over ACDF alone:
- Superior Fusion Success at 1 year: The study’s primary endpoint demonstrated a 44.3% higher composite fusion rate of CCF over ACDF (61.0% vs 16.7%, p<0.001) using a strict definition of composite fusion. Fusion was deemed a success if all three consecutive levels demonstrated motion of less than 2 degrees on flexion-extension radiographs and continuous bridging bone was exhibited across the endplates of all three segments on thin-slice CT scans. Results were reported by an independent core imaging lab and verified by multiple radiologists.
- Dramatic Difference in Revision Rates: Across all ACDF subjects followed through study completion, 22.8% (13/57) required subsequent surgical intervention (primarily due to symptomatic nonunion), compared to 1.7% (1/59) in the CCF arm.
- Overall Safety Success at 2 years: The study’s secondary endpoint measured overall safety success at 2 years using a composite of fusion success, lack of subsequent surgical interventions, maintenance or improvement in neurological success, and Neck Disability Index (NDI) improvement. The CCF arm exhibited a superior composite overall safety success rate at 24 months compared to the ACDF arm (CCF=50.8%, ACDF=22.8%, p<0.002).
- No Increase in procedure-related Adverse Events: 3-level CCF with PCSS demonstrated statistically lower procedure-related adverse events than 3-level ACDF (p=0.005).
These findings underscore the transformative potential of CCF with the PCSS device in managing degenerative disc disease in high-risk cervical fusion patients. With minimal added operative morbidity, CCF delivers significant improvement to long-term outcomes over the current standard of care. As such, results from this pivotal FUSE study represent a consequential advancement that redefines the standard of care for patients with multilevel disease.
Dr. Pierce D. Nunley, MD, the Director of the Spine Institute of Louisiana and a Principal Investigator in the FUSE Study, commented on the significance of the findings, stating, “The results from this study provide very compelling evidence for the use of circumferential cervical fusion with PCSS over the standard ACDF treatment for multilevel cervical degenerative disc disease. CCF patients had significantly higher fusion rates and greater improvements in patient-reported symptoms and overall quality of life. Furthermore, the Secondary Surgical Intervention (SSI) rates demonstrate the durability of CCF with PCSS: only 1.7% of CCF subjects (1/59) who completed the study required SSI, compared to 22.8% of ACDF subjects (13/57). This study should cause spine surgeons and payors to re-examine their preferred approach to treating 3-level cervical DDD.”
Jeff Smith, Chief Executive Officer of Providence Medical Technology, remarked, “The findings from the FUSE study mark a milestone in spinal surgery. These outcomes unequivocally demonstrate that 3-level CCF with CORUS PCSS has superior efficacy for spinal fusion and that 3-level ACDF fusion rates are unacceptably low. The high rates of 3-level ACDF failures and reoperation underscore how these patients need more to heal properly and achieve positive outcomes. The strength of this clinical evidence suggests that CCF with CORUS PCSS should become the new standard of care for multilevel fusion patients.”
For more information about the FUSE study and its implications, please visit: www.providencemt.com
The FUSE Clinical Study aims to redefine the standard of care for this prevalent condition through rigorous scientific inquiry and innovative treatment approaches. https://clinicaltrials.gov/study/NCT04229017
Indications for Use:
CORUS™ Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
CORUS PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
CORUS PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).
CORUS PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.
CORUS PCSS is to be used with autogenous bone and/or allogenic bone graft.
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SOURCE Providence Medical Technology, Inc.