Synergy Spine Solutions earned the FDA’s premarket approval for its Synergy Disc, according to a Feb. 27 news release.
The device is approved for 1-level cervical disc replacement at C3 to C7 for patients with degenerative disc disease. Approval is supported by findings from an Investigational Device Exemption. Synergy Spine also has more than 10 years of clinical data backing the device from more than 10 countries outside the U.S.
The IDE study found the Synergy Disc’s primary endpoint of composite clinical success was 87.1%, and 91.7% of patients who had the disc achieved a clinically meaningful improvement on the Neck Disability Index at 2 years. Synergy Disc patients also had higher overall patient satisfaction compared to anterior cervical discectomy and fusion 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,” Josh Butters, CEO of Synergy Spine Solutions, said in the release. “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.”
