Zimmer Biomet has announced that the US Food and Drug Administration (FDA) has approved an extension to the Mobi-C Cervical Disc labelling to include seven-year clinical results. The updated data remain consistent with the previous findings at two and five years, namely, that at seven years of follow-up, Mobi-C is statistically non-inferior in terms of overall study success for one-level use and is statistically superior in terms of overall study success for two-level use when compared to anterior cervical discectomy and fusion (ACDF). The Mobi-C Cervical Disc is a leading option for cervical total disc replacement (cTDR) that is designed to maintain patient range of motion post-surgery.
This FDA labeling update follows the recent publication of the seven-year follow-up data in the January 2018 issue of the peer-reviewed International Journal of Spine Surgery, as well as multiple podium presentations of the seven-year follow-up data at the International Society for the Advancement of Spine Surgery annual conference in 2018 (ISASS; 11—13 April 2018, Toronto, Canada) and the 2017 annual meeting of the North American Spine Society (NASS; 25—28 October, Orlando, USA).
The prospective, randomised clinical trial compared cTDR with Mobi-C to ACDF and followed almost 600 patients through seven years. The study showed that cTDR with Mobi-C was associated with nominally lower pain scores, maintained range of motion, less adjacent level degeneration and adjacent level subsequent surgery, as well as a lower rate of secondary surgery compared to ACDF.
“The seven-year results hold immense validation for Mobi-C, demonstrating clinical superiority—considering efficacy, safety, and repeat surgeries—of two-level cervical total disc replacement compared to ACDF,” said Rebecca Whitney, general manager of Zimmer Biomet’s Spine division. “With multiple podium presentations at top industry conferences educating the medical community on the key data, publication of the full data set in a leading spine journal, and now the FDA’s approval of our label extension to include these significant findings out to seven years, we are well-positioned to continue the growth and expanded adoption of Mobi-C with orthopaedic and neurosurgeons to treat even more patients indicated for cervical total disc replacement who desire maintained range of motion post-surgery.”