The Mobi-C Cervical Disc is one of the most widely used cervical discs in the world. First implanted in France in November 2004, Mobi-C has been implanted in more than 75,000 spinal levels in 25 countries.
A total of 599 patients were involved in the Mobi-C U.S. clinical trial, which represents the largest concurrent clinical trial ever conducted for cervical disc replacement. Mobi-C received FDA approval in August of 2013, making it the first cervical disc with both one and two- level indications.
Mobi-C contains patented mobile bearing technology that allows the polyethylene core to slide and rotate inside the disc for self- adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine.
Mobi-C provides bone sparing fixation without chisel cuts into the small vertebral bodies of the cervical spine, making it bone sparing.
In the one-level study, Mobi-C demonstrated non-inferiority to anterior cervical discectomy and fusion (ACDF) as reflected in the primary composite endpoint. In the two-level study Mobi-C demonstrated SUPERIORITY to ACDF in the primary composite endpoint. Key results from the two-level study include:
Overall trial success was 60.8% for Mobi-C and 34.6% for fusion, which represents statistical superiority (p=0.0002). The rate of subsequent surgeries at the operated level for Mobi-C was 5.6% versus 17.1% for fusion.