FDA OKs Providence Medical’s CORUS Posterior Cervical Stabilization System

Providence Medical Technology has received U.S. Food and Drug Administration (FDA) clearance for its CORUS posterior cervical stabilization system (PCSS) to treat up to three-level cervical degenerative disc disease (DDD).

CORUS PCSS is posterior spinal instrumentation with integrated screw fixation to provide immobilization and stabilization of spinal segments. It’s placed in a posterior surgical approach and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.

The FDA nod was based on the FUSE IDE study of 227 patients aged 18 to 80 with symptomatic cervical DDD at three contiguous levels. Subjects received either anterior cervical discectomy and fusion (ACDF) or circumferential cervical fusion (CCF) with CORUS. Analysis was done on over 200 subjects at one year of follow-up, and 100 patients at two years.

At one year, 44.3% higher composite fusion rate of CCF was shown over ACDF. 22.8% of ACDF subjects needed subsequent surgical intervention, mainly because of symptomatic nonunion. Only 1.7% of patients in the CCF arm needed another surgery.

The CCF arm also showed superior composite overall safety success rate at two years (50.8%) compared to ACDF (22.8%). Three-level CCF with PCSS demonstrated statistically lower procedure-related adverse events than three-level ACDF.

Providence Medical lauded the findings from the pivotal FUSE study as a consequential advancement that redefines standard of care for patients with multilevel DDD.

“The findings from the FUSE study mark a milestone in spinal surgery,” said Providence CEO Jeff Smith. “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.”