The device has gone into people in more than 25 countries since its first implantation in France in 2004.
In 2013, Mobi-C became the first cervical disc to win U.S. FDA approval to treat more than one level of the cervical spine.
The FDA determined Mobi-C to be statistically superior to fusion at 7 years for two-level cervical disc replacement, according to ZimVie. The basis of the conclusion was the primary study endpoint of a prospective, concurrently controlled and randomized, multi-center clinical trial. The company added that at 10 years, all patient-reported outcomes were equivalent to or improved from seven years.
More about the Mobi-C from ZimVie
“Mobi-C is differentiated by substantial, long-term clinical data, and we are proud to announce this milestone, reflecting tens of thousands of patient lives restored with our novel device,” Rebecca Whitney, global president of ZimVie Spine said in a news release.
“As we mark the 10-year anniversary of Mobi-C FDA approval for treatment of one and two levels of the cervical spine, we are excited to embrace 2023 as ‘the Year of Mobi-C’ by acknowledging and celebrating throughout the year the clinical success our surgeon customers have realized for their patients.”
Dr. Armen Khachatryan is an orthopedic surgeon at The Disc Replacement Center in West Jordan, Utah. He participated in the Mobi-C Investigational Device Exemption study over a decade ago. Khachatryan said in the news release that he was encouraged that disc replacement has become an emerging standard of care for patients with cervical disc degeneration. (Note: Common post-operative risks from surgery with the Mobi-C include pain in the neck, arm, back, shoulder, or head, and dysphagia.)
“ZimVie’s dedication to this space has enabled so many patients to benefit from the technology. … I sincerely hope that this transition from fusion to motion-preserving disc replacement technology will not only continue but accelerate in the coming years,” Khachatryan said.
