FDA clears CORUS™ PCSS for multilevel circumferential
cervical fusion procedures based on results from the prospective,
multicenter, randomized, controlled FUSE Study
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.
CONTACT- providence@providencemt.com
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SOURCE Providence Medical Technology, Inc.