ZimVie Receives Approval For Hybrid CDA and ACDF Study Using Mobi-C Cervical Disk Prosthesis

ZimVie Inc., a global life sciences leader in the dental and spine markets, has received approval from the U.S. Food and Drug Administration (FDA) to commence its Mobi-C® Cervical Disc Hybrid Investigational Device Exemption (IDE) study. The study will focus on patients receiving simultaneous cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) at adjacent levels between C3 and C7. The study aims to assess the efficacy of this hybrid construct, providing both clinical and economic benefits.

Mobi-C, the cervical disc prosthesis developed by ZimVie, has unique low-profile endplates that eliminate the need for keel cuts or additional hardware that might interfere with adjacent level implants. This feature makes it an attractive choice for surgeons performing two-level disc replacement and is expected to prove beneficial in hybrid constructs with fusion at an adjacent level.

Mobi-C is known as the first cervical disc prosthesis approved by the FDA for reconstruction at both one and two levels (C3-C7). This cobalt chromium alloy and polyethylene mobile-bearing prosthesis simplify insertion, eliminating the need for bone chiseling or vertebral anchorage with screws or keels. It is indicated for patients requiring disc reconstruction following discectomy, offering improved mobility. Additional companies including Medtronic, Nuvasive, Centinel Spine, and Spinal Kinetics now have 2-level artificial discs approved by the FDA.

Artificial disc replacement is a surgical procedure that involves the removal of a damaged or deteriorated spinal disc, replacing it with an artificial disc. This procedure is typically recommended for patients suffering from degenerative disc disease who have not experienced relief from conservative treatments like physical therapy or medication. A key advantage of artificial disc replacement is that it offers an alternative to spinal fusion surgery, which permanently joins two adjacent vertebrae. Unlike fusion surgery, artificial disc replacement allows for the preservation of motion in the treated area. The recovery period following artificial disc replacement varies depending on the patient and the extent of the surgery. However, most patients can generally return to their normal activities within a few weeks after the procedure.

Cervical artificial disc replacement has become increasingly popular over the last decade and the current global market for disc replacement (cervical and lumbar) is approximately $3 billion but expected to double over the next five years. Approximately 900,000 total spine surgeries are performed in the U.S. every year.

A recent long term prospective study published in the International Journal of Spine Surgery has highlighted the superiority of cervical artificial disc replacement (C-ADR) over anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical degenerative disc disease. C-ADR involves the replacement of a damaged disc with an artificial one, whereas ACDF involves the fusion of adjacent vertebrae using bone grafts. Both procedures are effective, but C-ADR stands out by preserving motion in the treated area. This preservation of motion is particularly crucial for younger patients as it can help reduce the risk of adjacent segment degeneration. The study, which spanned a 10-year follow-up period, revealed that patients who underwent C-ADR achieved a higher rate of overall success. This success was defined by improvements in neck disability index (NDI) scores and the maintenance or enhancement of motion at the surgical levels.