ZimVie’s Mobi-C Hybrid Gains IDE Approval From the FDA

The U.S. Food and Drug Administration (FDA) has awarded Investigational Device Exemption status to ZimVie Inc.’s Mobi-C Cervical Disc Hybrid.

The decision authorizes ZimVie to begin enrolling U.S. patients in a study that will follow participants 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 more than 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 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, according to ZimVie.
 
“The FDA approval of the IDE application will allow us to move forward with this important study,” said Kee D. Kim, M.D., professor and chief of Spinal Neurosurgery at the University of California, Davis, and a study investigator. “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 study, which may ultimately lead to more patients gaining access to the most appropriate treatment.”

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

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). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling or other vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
 
“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,” ZimVie Spine Global President Rebecca Whitney stated. “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. We are pleased to be at the forefront of important clinical studies to make motion preservation a reality for more patients.”
 
ZimVie develops, manufactures, and delivers products and solutions designed to treat various spine pathologies and support dental tooth replacement and restoration procedures. The company was founded in March 2022 as an independent, publicly traded spin-off of the Dental and Spine business units of Zimmer Biomet. From its Westminster, Colo., headquarters and additional global facilities, the company serves customers in more than 70 countries worldwide.