Synergy Spine Solutions has secured U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the Synergy Disc for one-level indications at C3-C7. The Synergy Disc was superior to fusion control on the primary endpoint of composite clinical success.  

The Synergy Disc is a motion-preserving artificial cervical disc designed to treat degenerative disc disease (DDD) of the cervical spine. It is touted as the first and only artificial cervical disc designed to improve anatomic alignment and to provide intentional motion preservation, using time-tested and trusted materials. The Synergy Disc’s FDA approval is supported by clinical evidence generated through a prospective clinical study conducted under a U.S. Investigational Device Exemption (IDE). The company also has over a decade of clinical experience with the Synergy Disc outside the United States in more than 10 countries, where the device has been commercially available and implanted in thousands of patients.

“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,” Synergy Spine Solutions CEO Josh Butters stated. “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.”

IDE study results demonstrated that the Synergy Disc achieved superiority in composite clinical success compared to the anterior cervical discectomy and fusion (ACDF) control, with the following results at 24 months:

• The Synergy Disc primary endpoint of composite clinical success was 87.1%, achieving superiority (p<0.0001) to the fusion control.
• 91.7% of patients in the Synergy Disc group achieved a clinically meaningful improvement on the Neck Disability Index at two years, compared to 75.2% in the fusion group. 
• The mean Neck pain score of 15.6 (0-100 VAS) in the Synergy Disc group was lower than 30.2 in the fusion group.
• Synergy Disc patients had lower worst arm pain scores (15.0) than the fusion group (32.2). 
• Disc angle in the Synergy Disc group increased from 2.6 pre-operatively to 6.5 degrees at 24 months. 
• Overall patient satisfaction was higher in the Synergy Disc group at 84.5% compared to 61.6% in the fusion group.

The Synergy Disc is intended for use at one cervical level (C3 through C7) after removing a degenerated cervical disc and addresses both motion preservation and spinal alignment in a single device. Built with input from practicing surgeons and using trusted orthopedic materials, the Synergy Disc supports consistent surgical outcomes and reliable postoperative imaging.

“Cervical disc degeneration affects a significant and growing patient population in the U.S., and the demand continues to accelerate for motion-preserving surgical options,” Synergy Spine Solutions Chief Medical Officer Neil Duggal, M.D., said. “Bringing the Synergy Disc to the U.S. market provides surgeons with access to a technology that preserves motion while addressing segmental alignment. This will significantly increase the addressable patient population and represents an important evolution in cervical disc replacement technology.”

Synergy Spine Solutions plans to begin marketing the Synergy Disc in the United States this spring. The Synergy Disc is also being evaluated in a separate U.S. IDE study for two-level indications. The two-level trial is fully enrolled, and two-year follow-up will be completed later this year. The Synergy Disc is limited to investigational use for two-level indications.

Synergy Spine Solutions is a medical device company developing motion-preserving technologies for treating degenerative disc disease while supporting the spine’s natural curvature. Its flagship product, the FDA-approved Synergy Disc, features a built-in six-degree lordotic core designed to preserve motion and improve sagittal alignment.