Orthofix’s M6-C artificial disc is being evaluated for contiguous two-level symptomatic cervical radiculopathy, according to an Aug. 2 news release.
Four things to know:
1. The first patient implant was completed by spine surgeon Todd Lanman, MD; 263 patients were enrolled in the study.
2. The FDA is conducting a U.S. Investigational Device Exemption study to compare the M6-C artificial disc and the anterior cervical discectomy and fusion for treating two-level symptomatic cervical radiculopathy.
3. Dr. Lanman said: “The M6-C artificial cervical disc two-level study will provide additional data to validate the effectiveness of disc replacement over fusion in patients suffering from degeneration in two contiguous levels.”
4. Previous long-term studies have shown patients who received the M6-C in an artificial cervical disc single-level clinical trial “continue to have statistically significant benefits at three and four years” compared to anterior cervical discectomy and fusion patients.”