Orthofix Medical Inc. announced it has received FDA approval of the M6-C artificial cervical disc, a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration.
Indicated as an alternative to cervical fusion, the M6-C disc is designed to restore physiologic motion to the spine, according to a company press release. By restoring biomechanical function at the treated level after native disc removal, the release noted the M6-C artificial cervical disc preserves motion and potentially reduces subsequent degeneration of adjacent vertebral segments.
In a premarket approval study, researchers evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression in patients with degenerative cervical radiculopathy requiring surgical intervention. At 24 months, results showed meaningful clinical improvement in the Neck Disability Index in 90.5% of patients who received the M6-C disc vs. 79.9% of patients who underwent ACDF. The release noted 91.2% of patients in the M6-C disc group had a meaningful clinical improvement in arm pain score compared with 77.9% of patients in the ACDF group. Patients in the M6-C disc group experienced preserved range of motion in flexion-extension and lateral bending, as well as a lower rate of opioid use, results showed. Additional surgery at the treated level was needed in 4.8% and 1.9% of patients in the ACDF group and M6-C disc group, respectively, according to the release.
“With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients,” Brad Mason, president and CEO of Orthofix, said in the release. “In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity Elite allograft, a market-leading allograft developed in partnership with MTF Biologics. The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth.”
The release noted the M6-C artificial cervical disc is expected to be released in 2019 through a controlled, limited market launch in the United States accompanied by an extensive training and education curriculum for surgeons.