Synergy Spine Solutions has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the Synergy Disc, expanding cervical disc replacement options for patients in the country.
The approval follows clinical evidence showing superiority to fusion control on the primary endpoint of composite clinical success.
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The Synergy Disc is intended for one-level indications at C3–C7, and the approval advances a new category of artificial disc technology designed for preserving motion and improving alignment of the spine.
It is an artificial cervical disc intended for patients with degenerative disc disease of the cervical spine, and is supported by a prospective clinical study carried out under an investigational device exemption (IDE) in the US.
IDE study results at 24 months showed an 87.1% composite clinical success rate with the Synergy Disc.
At two years, 91.7% of patients with the Synergy Disc achieved clinically meaningful improvement on the Neck Disability Index, compared to 75.2% in the fusion group.
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By GlobalDataThe mean neck pain score was 15.6 for Synergy Disc recipients, compared to 30.2 in the fusion group. Patients reported lower worst arm pain scores (15.0) than those in the fusion group (32.2).
The disc angle increased from 2.6° pre-operatively to 6.5° at 24 months. Overall patient satisfaction reached 84.5% for the Synergy Disc group versus 61.6% in the fusion group.
Synergy Spine Solutions CEO Josh Butters said: “FDA approval of the Synergy Disc marks a pivotal moment– bringing US surgeons and patients the first motion-preserving disc that also corrects focal spinal alignment with its unique lordotic core.
“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.”
Commercialisation of the device in the US is planned for early 2026.
A separate IDE study is underway for two-level indications; this trial is fully enrolled, with a two-year follow-up set for completion later this year.
In 2024, Synergy completed a Series A funding round totalling $30m to support clinical trials and regulatory approvals for the Synergy Disc.
