The study evaluates the Mobi-C cervical disc in hybrid use. Patients in the study receive simultaneous cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) at adjacent levels between C3 and C7. ZimVie says the hybrid construct — where disc replacement and fusion occur in one surgery — can represent the best two-level treatment. The company says it provides a clinical benefit to patients and surgeons, plus economic benefit to stakeholders.
Mobi-C initially received FDA approval for one and two levels in 2013. Surgeons have implanted more than 200,000 Mobi-C implants for cervical disc replacement since 2004. Westminster, Colorado-based ZimVie says it remains the market-leading device for cervical disc replacement.
Contrary to some competitive implants, Mobi-C features low-profile endplates, the company says. These eliminate the need for keel cuts or additional hardware that could interfere with implants at an adjacent level.
ZimVie plans to begin enrollment for the study over the next several months. It expects to conduct the study with multiple surgeons across six sites over the next five years.
Rebecca Whitney, global president of ZimVie Spine, said the IDE puts the company “at the forefront” of important clinical studies. The company aims to “make motion preservation a reality for more patients.”
“The decision to move forward with the Mobi-C hybrid study demonstrates our ongoing leadership and significant investment in continuing to develop the cervical arthroplasty market,” said Whitney. “We are committed to and passionate about driving the expansion of this market to provide a greater number of patients with the gift of motion.”
