Orthopedic surgeons at the Dallas-based Center for Disc Replacement at Texas Back Institute implanted Orthofix Medical's M6-C artificial cervical disc in the first patients.
Five insights:
1. Center for Disc Replacement Co-medical Directors Scott Blumenthal, MD, Jack Zigler, MD, and Richard Guyer, MD, implanted the disc in four patients with single-level cervical disc degeneration.
2. The M6-C disc is intended to replace an intervertebral disc damaged by cervical disc degeneration.
3. The M6-C is the only artificial disc available in the U.S. that enables compression like a natural disc. Its artificial viscoelastic nucleus and fiber annulus mimic a natural disc's anatomic structure.
4. Orthofix is planning a controlled, limited U.S. market launch of the disc in 2019. It will provide extensive surgeon training and education in conjunction with the rollout.
5. The FDA approved the M6-C disc in February. The device previously received CE Mark approval for international territories, and more than 45,000 M6-C discs have been implanted outside the U.S.
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