The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April.
The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said.
Pre-market approval of the device came based on results from an FDA investigational device exemption study of the system which evaluated the safety and effectiveness of the M6-C as compared to anterior cervical discectomy and fusion for treating symptomatic cervical radiculopathy with or without cord compression, the company said.
Two-year results from the trial indicated that 90.5% of patients who received the disc showed a meaningful clinical improvement on the Neck Disability Index versus only 79.9% in the ACDF cohort, as well as improvements in arm pain in 91.2% of M6-C patients, higher than the 77.9% reported in ACDF patients.
Data from the trial indicated that patients who received the M6-C disc showed a preserved range of motion in flexion-extension and lateral bending.
A total 80.6% of M6-C disc patients and 85.7% of ACDF patients reported taking pain medications for their cervical spine condition, Orthofix said. At 24 months, 14% of M6-C patients reported still taking pain medications, compared to 38.2% of the ACDF cohort.
Additional surgeries at the treated level was required in only 1.9% of M6-C patients, lower than the 4.8% rate for ACDF patients, the company said.
“Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many of these patients, the M6-C artificial cervical disc will give us the ability to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling them to regain motion and return to their normal activities,” M6-C artificial cervical disc IDE study investigator Dr. Rick Sasso of Indianapolis’ Indiana University School of Medicine said in a prepared statement.
Orthofix said it plans to launch the M6-C artificial cervical disc this year through a controlled, limited market launch in the U.S. with an extensive training and education program. The device already has CE Mark approval in the European Union.
“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. 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,” Orthofix prez & CEO Brad Mason said in a press release.
Earlier this week, Orthofix said that it acquired Florida-based medical device distributor Options Medical for an undisclosed amount.