Austin, Texas-based LDR's Mobi-C Cervical Disc has been approved by the FDA for two-level indications, making it the only cervical disc in the country approved to treat more than one level in the cervical spine. The Mobi-C is a cobalt chromium alloy and polyethylene prosthesis. It is designed to be bone-sparing and serve as an alternative to fusion.
LDR completed the rigorous process of obtaining FDA pre-market approval, including conducting a 24-month clinical study. Results showed the Mobi-C had a success rate of 69.7 percent compared with ACDF's rate of 37.4 percent.
Patients in the study were also able to return to work at 45.9 days with the Mobi-C compared with 66.8 days for ACDF.
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