ZimVie announces FDA approval to launch Mobi-C Hybrid study

ZimVie announced that on September 7, 2023, the U.S. Food and Drug Administration approved its Mobi-C Cervical Disc Hybrid Investigational Device Exemption, IDE, application. The decision authorizes ZimVie to begin enrolling U.S. patients in the study, which will follow patients who receive simultaneous cervical disc arthroplasty, CDA, and anterior cervical discectomy and fusion, ACDF, at adjacent levels between C3 and C7. In some cases, the best two-level treatment may be just such a hybrid construct, where the disc replacement and fusion can be completed in one surgery, providing a clinical benefit to the patient and surgeon as well as an economic benefit to stakeholders in the healthcare delivery system. Surgeons have implanted over 200,000 Mobi-C implants for cervical disc replacement at one level or two contiguous levels since 2004. In 2013, Mobi-C became the first cervical disc approved for one and two levels by the FDA and remains the market-leading device for cervical disc replacement