Spineart Announces FDA Approval ofBAGUERA® C Cervical Disc

Spineart announces that the BAGUERA® C cervical disc has received FDA approval for 1 and 2 contiguous levels, expanding access in the United States to a motion-preserving solution for patients suffering from cervical disc disease. 

As one of Spineart’s foundational technologies and a cornerstone of its cervical portfolio, BAGUERA® C brings nearly two decades of international clinical experience to a market with relatively few cervical disc replacement options. Since its introduction, over 80,000 devices have been sold worldwide, establishing a long track record of clinical use.  

The FDA approval is supported by two randomized controlled trials with nearly 600 patients enrolled in the United States. Additional clinical evidence, including a 10-year follow-up study published in The European Spine Journal in 2023, demonstrated that 85% of implants maintained motion a decade after treatment, providing long-term data on preservation of motion at the treated level. 

“This approval represents an important milestone for Spineart and for surgeons seeking an alternative to spinal fusion in appropriately selected patients,” said Jerome Trividic, CEO of Spineart. “With nearly 20 years of international experience and proven long-term clinical outcomes, BAGUERA® C delivers robust evidence and real-world performance.” 

The addition of BAGUERA® C in the United States further strengthens Spineart’s comprehensive portfolio of spine technologies and reinforces the company’s commitment to providing surgeons with innovative solutions backed by clinical evidence, global experience, and a relentless focus on patient outcomes. 


➡️ Source: Press Release