Centinel Spine has secured US Food and Drug Administration (FDA) approval for two-level use of its prodisc C Nova cervical artificial disc, expanding its range of motion-preserving options for patients with degenerative cervical spine conditions.
The approval means three devices in the company’s prodisc cervical portfolio — prodisc C Nova, prodisc C Vivo and prodisc C SK — are now FDA-approved for both one- and two-level total disc replacement (TDR) procedures.
The milestone strengthens Centinel Spine’s Match-the-Disc strategy, which aims to give surgeons greater flexibility in selecting implants to suit individual patient anatomy and the needs of each treated spinal level.
"This is welcome news for spine surgeons and patients," said Christopher Summa, Orthopedic Spine Surgeon with Sutter Health in Santa Cruz, CA.
"Two-level approval expands the clinical application of the prodisc C Nova technology and provides me with another excellent prodisc option. I can now select among three distinct prodisc cervical devices, all with one-and two-level FDA approval. This optionality benefits my patients by allowing me to optimize implant fit and fixation based on anatomical variation."
Currently available in the U.S. on a limited-release basis, prodisc C Nova has been in clinical use outside the country since 2009.
The device features flat endplates and low-profile keels designed to accommodate particular vertebral anatomy. It also incorporates prodisc CORE technology, the kinematic foundation of Centinel Spine’s prodisc platform.
The company’s broader approach centres on offering multiple implant designs to preserve spinal movement while allowing surgeons to select devices based on anatomical differences and disease progression.
"This approval represents another important advancement for our Match-the-Disc portfolio," notes Steve Murray, CEO of Centinel Spine.
"With three distinct prodisc cervical devices now approved for both one- and two-level use, we continue to expand our cervical portfolio and advance our strategy of providing multiple implant designs to address differences in patient anatomy and disease advancement. The two-level approval of prodisc C Nova represents another important milestone in the continued evolution of our Match-the-Disc approach."
Centinel Spine focuses exclusively on total disc replacement for the cervical and lumbar spine, positioning motion preservation as an alternative to traditional spinal fusion, which eliminates movement at the fused segment.
The company’s prodisc platform includes multiple implant options for both cervical and lumbar procedures. Centinel Spine says the portfolio is designed to help surgeons match implant characteristics to individual patient anatomy while preserving spinal movement.
