ZimVie Announces FDA Approval to Launch Mobi-C Hybrid Study

Decision clears the way for enrollment of U.S. patients in a groundbreaking clinical study of cervical arthroplasty adjacent to fusion

WESTMINSTER, Colo., Sept. 26, 2023 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today 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.

Unlike some competitive implants, the Mobi-C cervical disc features low-profile endplates that do not require keel cuts or additional hardware that could interfere with implants at an adjacent level. This has made Mobi-C a compelling choice for surgeons performing two-level disc replacement, and will likely prove attractive in hybrid constructs with fusion at an adjacent level.

Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery at the University of California, Davis, and one of the investigators in the study, shared, “The FDA approval of the IDE application will allow us to move forward with this important study. Good clinical data is an important step in broadening the approved indications for cervical disc replacement in hybrid constructs with fusion at an adjacent level. I am delighted to be part of this groundbreaking study, which may ultimately lead to more patients gaining access to the most appropriate treatment.”