FDA has approved Orthofix Medical’s M6-C artificial cervical disc for use in patients with intractable degenerative cervical radiculopathy, putting it in competition with rival products sold by Medtronic and Zimmer.
The device is designed to replace an intervertebral disc damaged by cervical disc degeneration and thereby enable the patient to move their spine.
Orthofix paid $45 million upfront to buy the device’s developer, Spinal Kinetics, last year in a deal that tied it to $60 million in regulatory and commercial milestones.
The implant will compete with products including Medtronic’s Prestige LP and Zimmer Biomet’s Mobi-C.
Observers have questioned whether the design of M6-C will permit a greater range of motion (ROM) than other devices, though. A comparison of the available devices published in Neurosurgical Review noted that the ROM achieved at 24 months by first-generation devices including Medtronic’s and Zimmer Biomet’s was “uniformly greater” than that seen in the M6-C feasibility trial. A separate head-to-head comparison between the Zimmer device and Orthofix's found Zimmer’s device yielded a greater range of extension.
Orthofix is planning a limited rollout of the device in the U.S. this year accompanied by a training and education program. The product has been cleared for use in the European Union since 2006 and surgeons have used 45,000 of the devices outside the U.S. Progress in the U.S. has been slower due to the need to run a trial, which was registered on ClinicalTrials.gov in 2012, and wait 15 months for FDA to review and approve the application.
When treating such patients, physicians can now use the device to replace damaged intervertebral discs. The device is designed to mimic the structure of natural discs and thereby provide shock absorption and “a controlled range of motion when the spine transitions in its combined complex movements.”
The devices aim to treat cervical radiculopathy, which occurs when wear and tear drives changes to the discs that make up the spine. These degenerating discs lose height, causing the vertebrae to move closer together and ultimately to the formation of bone spurs. Bone spurs can irritate nerves, resulting in pain, muscle weakness and numbness. Disc herniation can also cause the condition.
A minority of patients have intractable forms of the condition that require surgery to alleviate the symptoms.
The FDA approval clears the device for use in patients who have confirmed degenerative cervical radiculopathy by radiographic imaging and are either still suffering after six weeks of conservative treatment, or have progressive neurological symptoms that suggest they may suffer permanent impairment.