Providence Medical Technology earned FDA clearance for its Corus posterior cervical stabilization to treat up to three-level cervical degenerative disc disease, the devicemaker said July 11.
Clearance was based on an investigational device exemption study across 18 U.S. sites, according to a news release. The study enrolled 227 patients with symptomatic cervical degenerative disc disease at three contiguous levels. Subjects either had anterior cervical discectomy and fusion or ACDF plus posterior cervical fusion.
The study found a 44.3% higher composite fusion rate with patients who had surgery with the Corus device compared to the ACDF group. Among the ACDF patients, 22.8% needed follow-up surgery compared to 1.7% in the Corus group.
"The high rates of 3-level ACDF failures and reoperation underscore how these patients need more to heal properly and achieve positive outcomes," Jeff Smith, CEO of Providence Medical Technologies, said in the release. "The strength of this clinical evidence suggests that CCF with CORUS PCSS should become the new standard of care for multilevel fusion patients."