The FDA granted Zimmer Biomet's request to extend its Mobi-C Cervical Disc labeling to include seven-year clinical results.
Here are five things to know:
1. The results are consistent with Zimmer Biomet's findings at two and five years.
2. At the seven-year mark, Zimmer Biomet found the Mobi-C disc was successful for two-level use when compared to anterior cervical discectomy and fusion.
3. Zimmer Biomet followed nearly 600 patients who were implanted with the Mobi-C disc for seven years. The study showed the disc was associated with lower pain scores. Patients maintained range of motion and fewer subsequent surgeries were necessary.
4. The Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.
5. The Mobi-C is the first cervical disc prothesis approved by the FDA for cervical disc reconstruction at one and two levels.