Geneva, Switzerland, August,11, 2026
Spineart has announced that its BAGUERA® C cervical disc has received U.S. Food and Drug Administration (FDA) approval for use at one and two contiguous levels, expanding access in the United States to a motion-preserving treatment option for appropriately selected patients with cervical disc disease. The regulatory milestone strengthens Spineart’s cervical spine portfolio and brings a device with nearly 20 years of international clinical experience to the U.S. market. More than 80,000 BAGUERA C devices have been sold worldwide, providing a substantial history of clinical use. The FDA approval is supported by randomized controlled clinical studies involving nearly 600 patients in the United States and additional long-term clinical evidence.
FDA Approval Expands BAGUERA C Access
The BAGUERA C cervical disc is one of Spineart’s foundational technologies and a key component of its cervical spine portfolio. The newly announced FDA approval covers treatment at one and two contiguous levels, allowing the company to expand availability of its motion-preserving cervical disc technology to eligible patients in the United States. Cervical disc replacement is designed to preserve movement at the treated spinal level and represents an alternative to spinal fusion for appropriately selected patients. According to Spineart, the U.S. regulatory approval was supported by two randomized controlled trials that collectively enrolled nearly 600 patients in the United States. The clinical evidence provides a foundation for the device’s introduction into the U.S. market and adds to the substantial international experience accumulated since BAGUERA C was first introduced. The company highlighted the combination of clinical evidence, global experience and long-term follow-up as important factors supporting the technology’s U.S. expansion.
The FDA milestone also represents an important development for Spineart as it continues to broaden its portfolio of technologies designed for spinal surgery and patient care. The company said the U.S. addition of BAGUERA C strengthens its comprehensive spine technology offering and supports its objective of providing surgeons with innovative solutions backed by clinical evidence.
Long-Term Data Support Motion Preservation
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Beyond the U.S. clinical trials supporting the FDA approval, Spineart highlighted additional evidence from a 10-year follow-up study published in The European Spine Journal in 2023. The study reported that 85% of implants maintained motion after 10 years, providing long-term clinical data regarding preservation of movement at the treated spinal level. This long-term evidence adds to the body of clinical experience associated with BAGUERA C and provides information on the durability of motion preservation following treatment.
The availability of long-term clinical evidence is particularly relevant for cervical disc replacement technologies because maintaining motion at the treated level is a central objective of the procedure. Spineart said the combination of nearly two decades of international experience and long-term clinical outcomes provides surgeons with additional evidence when considering motion-preserving solutions for appropriately selected patients.
Spineart Strengthens U.S. Spine Technology Portfolio
Spineart CEO Jerome Trividic described the FDA approval as an important milestone for the company and for surgeons seeking an alternative to spinal fusion in appropriately selected patients. The company emphasized the device’s clinical evidence, international experience and real-world use as key elements of the BAGUERA C platform. With more than 80,000 devices sold globally, BAGUERA C enters the U.S. market following extensive international use. The FDA approval therefore represents both a regulatory achievement and a significant commercial expansion for Spineart’s cervical spine technology. The company continues to focus on quality, innovation and simplicity across its portfolio of spine surgery solutions and digital technologies.
The U.S. approval of BAGUERA C adds another FDA-cleared cervical disc replacement option for eligible patients with cervical disc disease and provides surgeons with access to a technology supported by randomized clinical trials and long-term follow-up data. The milestone reinforces Spineart’s position in the MedTech and spinal surgery market while expanding the company’s presence in the U.S. healthcare sector.
Source: Spineart press release
