FDA Clears Spineart’s BAGUERA C Cervical Disc for US Market
Surgeons in the United States now have access to the BAGUERA C cervical disc prosthesis following its FDA approval for one and two contiguous levels. This decision introduces a motion-preserving alternative to traditional spinal fusion, backed by nearly two decades of international clinical data and extensive human trials.
The regulatory green light arrives after two randomized controlled trials involving nearly 600 American patients. Beyond domestic testing, the device carries a significant global track record, with over 80,000 units implanted worldwide. A 2023 study published in The European Spine Journal bolstered the approval case, showing that 85% of patients maintained spinal motion a full decade after their initial procedure.
Jerome Trividic, CEO of Geneva-based Spineart, described the milestone as a vital step for surgeons seeking to offer patients long-term mobility rather than the rigidity associated with spinal fusion. By entering the US market with a mature, evidence-based product, the company aims to challenge the limited number of existing disc replacement options currently available to domestic hospitals.
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