The FDA-approved investigational device exemption findings, published in The Spine Journal, found that after 5 years, M6-C had 82.3% composite clinical success while ACDF had 67% CCS. Rates of subsequent surgical interventions were 3.1% for disc replacement and 5.3% for ACDF.
Patients with single-level symptomatic cervical radiculopathy with or without cord compression across 23 sites in the U.S. were evaluated for the study, according to a Nov. 29 news release.
The study concluded, “Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in re-operation rates or safety outcomes.”
A 2-level study for M6-C compared to ACDF is currently underway.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
