Louisville, Colorado, U.S., September 24, 2026
Synergy Spine Solutions has announced the publication of two-year clinical results for its FDA-approved Synergy Disc® in Spine Open, providing additional evidence on the performance of the cervical disc replacement device compared with anterior cervical discectomy and fusion (ACDF). The peer-reviewed study evaluated outcomes from a prospective U.S. Investigational Device Exemption (IDE) trial and reported higher composite clinical success, meaningful functional improvement, reduced neck and arm pain, and greater patient satisfaction among patients treated with the Synergy Disc. The findings also showed improvements in cervical alignment, supporting the device’s design approach combining motion preservation with a built-in 6-degree lordotic core. The Synergy Disc received U.S. FDA Premarket Approval in February 2026 for single-level use from C3 to C7 and is now commercially available in the United States.
Synergy Disc Demonstrates Clinical Success at 24 Months
The prospective multicenter study included 175 patients treated with the Synergy Disc across 20 U.S. sites and compared their outcomes with 192 propensity-matched historical ACDF control patients. The primary endpoint was composite clinical success at 24 months, incorporating improvement in Neck Disability Index (NDI) scores, maintenance or improvement in neurological status, and the absence of secondary surgery, radiographic failure and device-related serious adverse events. At the two-year assessment, 87.1% of Synergy Disc patients achieved composite clinical success, compared with 56.6% of the ACDF control group, meeting the study’s predefined superiority criteria. The study also reported clinically meaningful improvement in NDI scores in 91.7% of Synergy Disc patients versus 75.2% among fusion patients.
Reduced Pain and Higher Patient Satisfaction
The study reported differences in neck and arm pain outcomes between the Synergy Disc and historical fusion control groups. At 24 months, mean neck pain scores were 15.6 for Synergy Disc patients compared with 30.2 for ACDF patients on a 100-point visual analog scale. Worst arm pain scores were 15.0 for the Synergy Disc group versus 32.2 for the fusion group. Overall patient satisfaction reached 84.5% among Synergy Disc recipients compared with 61.6% in the ACDF control group. Researchers also observed improvements in cervical alignment among patients receiving the device. The disc angle increased from 2.6 degrees before surgery to 6.5 degrees at 24 months, indicating improvement in alignment at the treated spinal segment.
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Lordotic Design Supports Motion Preservation
The Synergy Disc is designed to address both motion preservation and cervical alignment following surgery. Unlike conventional cervical disc replacement designs primarily intended to maintain movement, the device incorporates a 6-degree lordotic core intended to restore alignment at the treated level while preserving motion. According to the company, migration resistance was incorporated as an explicit design goal. The device uses nickel-free titanium alloy endplates and an ultra-high molecular weight polyethylene core, features intended to support durability and postoperative imaging while providing an option for patients with nickel sensitivities. The company also reports that the device has been used clinically outside the United States for more than a decade and implanted in thousands of patients across more than 10 countries.
The publication adds longer-term clinical evidence to the development and regulatory history of the Synergy Disc, following its FDA Premarket Approval in February 2026. The two-year findings provide data across clinical success, function, pain, satisfaction and cervical alignment in patients undergoing cervical disc replacement. While the results are from the company’s reported clinical study and include a historical ACDF control group, the publication contributes additional peer-reviewed evidence concerning the performance of the device. Synergy Spine Solutions continues to position the Synergy Disc as a motion-preserving cervical implant designed to address both spinal movement and alignment in patients undergoing surgery for cervical disc disease.
Source: Synergy Spine Solutions press release
