The FDA has determined Mobi-C to be statistically superior to fusion at 7 years for two-level cervical disc replacement, based on the primary study endpoint of a prospective, concurrently controlled and randomized, multi-center clinical trial.1 At 10 years, all patient-reported outcomes were equivalent to or improved from 7 years.2
“Mobi-C is differentiated by substantial, long-term clinical data and we are proud to announce this milestone, reflecting tens of thousands of patient lives restored with our novel device,” noted
Dr.
Common post-operative risks from surgery with the Mobi-C include pain in the neck, arm, back, shoulder, or head, and dysphagia. For complete indications, contraindications, warnings, and risks on the Mobi-C Cervical Disc or to find more information on other ZimVie Spine solutions, please visit https://www.zimvie.com/en/spine.html.
About the Mobi-C Cervical Disc
Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling or other vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
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This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning ZimVie’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs, expectations, and assumptions of management and are subject to significant risks, uncertainties, and changes in circumstances that could cause actual outcomes and results to differ materially from the forward-looking statements. For a list and description of some of such risks and uncertainties, see ZimVie’s periodic reports filed with the
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References:
1 Radcliff K, Davis RJ, Hisey MS, et al. Long-term evaluation of cervical disc arthroplasty with the Mobi-C Cervical Disc: a randomized, prospective, multicenter clinical trial with seven-year follow-up. Int J Spine Surg 2017;11(4):244-262. DOI: https://doi.org/10.14444/4031
2 Kim K, Hoffman G, Bae H, et al. Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial. Neurosurgery. 2021;88(3):497-505. DOI: https://doi.org/10.1093/neuros/nyaa459
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