M6-C is intended to replace an intervertebral disc damaged by cervical disc degeneration and restore physiologic motion to the spine. It is indicated as an alternative to cervical fusion.
Recently, two-, three- and four-year data has been published demonstrating M6-C to be a safe and effective treatment for cervical disc degeneration compared to anterior cervical discectomy and fusion.
Seven key developments:
1. Orthofix received FDA approval for the M6-C in February 2019. The device received the CE Mark in Europe in 2014.
2. In April 2019, A U.S. Investigational Device Exemption study carried out at 23 clinical sites reported that patients treated with the M6-C disc reported better pain, function and quality of life scores than patients who underwent ACDF.
3. Two-year data published in The Spine Journal in January further demonstrated the efficacy of M6-C for the treatment of single-level symptomatic cervical radiculopathy with or without spinal cord compression.
4. Results of the study also highlighted a notable reduction of pain and opioid use for M6-C patients compared to ACDF patients.
5. In May, Orthofix released three- and four-year preliminary data that show M6-C patients “continue to have statistically significant benefits at three and four years” compared to ACDF patients, according to Frank Phillips, MD, an investigator in the study.
6. The follow-up study demonstrated that M6-C patients experienced an improvement in Neck Disability Index scores at three and four years compared to the ACDF group, with four-year results significantly better for the M6-C group.
7. Five-year data is currently being collected.
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