News

Synergy Spine Solutions announced that it has secured FDA premarket approval (PMA) for its Synergy Disc for single-level use between C3 and C7.

Based in Louisville, Colorado, Synergy Spine developed the Synergy Disc as a distinctive artificial disc system designed to preserve motion. It is intended to treat patients suffering from degenerative disc disease (DDD) of the cervical spine.

According to a company news release, the Synergy Disc is the first and only artificial disc created to enhance alignment while delivering intentional motion preservation, utilizing time-tested and trusted materials. FDA approval was supported by clinical data from a study conducted under an FDA investigational device exemption (IDE). The company also highlights a decade of clinical use outside the United States across more than 10 countries.

In its IDE study, the Synergy Disc demonstrated superiority in overall composite clinical success compared with the anterior cervical discectomy and fusion (ACDF) control at 24 months.

The device is indicated for use at a single cervical level (C3 through C7) following removal of a degenerated cervical disc. It is designed to address both motion preservation and spinal alignment within one implant. Synergy Spine noted that the disc is intended to promote consistent surgical results and dependable post-operative imaging.

“FDA approval of the Synergy Disc marks a pivotal moment– bringing U.S. surgeons and patients the first motion-preserving disc that also corrects focal spinal alignment with its unique lordotic core,” said Josh Butters, CEO of Synergy Spine Solutions. “We are thrilled with the clinical outcomes achieved in this study and this approval reflects years of focused development, clinical evaluation, and surgeon-led innovation aimed at solving persistent challenges in cervical disc replacement.”

Currently, the leading cervical disc on the market is the Highridge Mobi-C (formerly from ZimVie/Zimmer Biomet).

© Synergy Spine Solutions