Spineart receives FDA approval for its BAGUERA C cervical disc

Spineart, the Geneva-based medtech company specializing in spine surgery, has received FDA approval for its BAGUERA C cervical disc for one and two contiguous levels, expanding access in the United States to a motion-preserving solution for cervical disc disease.

Spineart, a medtech company based in Plan-les-Ouates in the canton of Geneva, has announced that its BAGUERA C cervical disc has received approval from the US Food and Drug Administration for one and two contiguous levels. The approval expands access in the United States to a motion-preserving solution for patients with cervical disc disease, in a market with relatively few cervical disc replacement options.

One of the company’s foundational technologies and a cornerstone of its cervical portfolio, BAGUERA C brings nearly two decades of international clinical experience, with more than 80,000 devices sold worldwide since its introduction. The FDA approval is supported by two randomized controlled trials enrolling nearly 600 patients in the United States. Additional clinical evidence includes a ten-year follow-up study published in The European Spine Journal in 2023, which found that 85 percent of implants maintained motion a decade after treatment.

The device offers surgeons an alternative to spinal fusion in appropriately selected patients, preserving motion at the treated level rather than immobilizing it. Its addition to the company’s US offering strengthens a portfolio of spine technologies spanning motion preservation, posterior fixation, interbody fusion, enabling technologies and biologics.

Spineart received the Prix de l’Économie Genevoise in 2022 for its contribution to technological and scientific innovation, commercial activity, job creation and ESG principles.