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.
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