The FDA approved Spineart’s Baguera C cervical disc for 1 and 2 contiguous levels, expanding the device’s availability in the U.S.
The disc is designed as a motion-preserving option for patients with cervical disc disease, according to an Aug. 11 news release from the company. More than 80,000 devices have been sold worldwide since its introduction.
The FDA approval was supported by two randomized controlled trials that enrolled nearly 600 patients in the U.S. Additional clinical evidence included a 10-year follow-up study published in The European Spine Journal in 2023. That study found 85% of implants maintained motion a decade after treatment.
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