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Model Mobi-C - Cervical Disc
FromZimVie Inc.
ZimVie Announces Over 200,000 Cervical Discs Have Been Replaced with Mobi-C. Mobi-C Cervical Disc was the ?rst cervical disc in the United States approved to treat more than one level of the cervical spine. Mobi-C was determined by the FDA to be statistically superior to fusion at 7 years for two-level cervical disc replacement, based on the primary study endpoint of a prospective, concurrently controlled and randomized, multi-center clinical trial.1 At 10 years, all patient-reported outcomes were equivalent to or improved from 7 years.3.4
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Mobi-C was first implanted in Europe in November 2004.
To receive approval in the United States, an Investigational Device Exemption (IDE) clinical trial was conducted involving 599 patients that began in April 2006. This study compared Mobi-C to the current standard of care, anterior cervical discectomy and fusion (ACDF), for both one and two-level indications.
Controlled Mobility
Restoring natural motion to the cervical spine
The controlled mobility of the patented mobile core is the foundation of Mobi-C. With vertebrae and neck muscle movement, the Mobi-C implant is free to twist and slide left-to-right, and front-to-back, as well as rotate.
A return to physiological mobility
The center of rotation at each level of the cervical spine is variable and constantly changing.4 Mobi-C was designed to adapt to the Instantaneous Axis of Rotation through its self-adjusting mobile core. The mobile core allows the vertebrae above and below the disc to move, to maintain normal neck motion.
Mobi-C moves with the spine and does not dictate a predetermined, fixed axis of rotation. This facilitates independent and coupled motion similar to natural cervical spine motion.
Mobi-C is composed of three parts: two metal plates and a medical grade polyethylene insert in between. The top plate rotates over the domed insert, allowing for a continuous path of cyclic movements: Flexion-Extension (FE), Lateral Bending (LB), and Axial Rotation (AR).