, /PRNewswire/ -- Providence Medical Technology announces FDA Clearance of its CORUSTM 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: 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 tha.
