Four things to know:
1. The FDA investigational device exemption trial followed up with patients for two years and compared disc replacement patients with anterior cervical discectomy and fusion patients.
2. Researchers found the overall composite success rate was statistically significantly greater in the artificial disc group compared with the fusion group after 24 months. The mean neck disability index for both groups improved significantly in both groups, and the disc replacement group had lower scores at follow-up points.
3. Rates of subsequent intervention was 2.2 percent in the disc replacement group and 8.8 percent in the fusion group.
4. Data from this trial was used in the FDA pre-market application for two-level indication approval, according to an April 21 news release.
