ZimVie: FDA Allows To Move Forward With Mobi-C Hybrid Study - Quick Facts

(RTTNews) - ZimVie Inc. (ZIMV) announced that on September 7, 2023, the FDA approved its Mobi-C Cervical Disc Hybrid Investigational Device Exemption application authorizing the company to begin enrolling U.S. patients in the study, which will follow patients who receive simultaneous cervical disc arthroplasty and anterior cervical discectomy and fusion at adjacent levels between C3 and C7. Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels, C3-C7.

The company plans to begin enrollment over the next several months and conduct the IDE study with multiple surgeons at six sites over the next five years.

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