The FDA has approved an update to LDR's Mobi-C Cervical Disc labeling to include five-year clinical results.
Here are six things to know:
1. At 60 months of follow-up, the Mobi-C device demonstrated superiority in overall trial success compared to the control anterior cervical discectomy and fusion treatment, which is the traditional option for treating cervical degenerative disc disease.
2. Mobi-C implanted at two contiguous levels showed an overall success rate of 62.8 percent, while the rate of success using ACDF was 34.1 percent.
3. The rate of subsequent surgery at the index level was lower for Mobi-C at 3.8 percent compared to 16.2 percent for ACDF.
4. The mean return to work time was 45.9 days for Mobi-C compared to 66.8 days for ACDF.
5. Mobi-C showed an 82 percent improvement in neck disability index based on success criteria compared to 56.6 percent for ACDF.
6. According to LDR President and CEO Christophe Lavigne, the FDA's approval of Mobi-C's labeling updated with five-year safety and efficacy data is another important milestone for LDR.