Spineart’s Motion-Preserving Artificial Cervical Disc Wins FDA Nod

Spineart’s Baguera C cervical disc prosthesis has obtained U.S. Food and Drug Administration (FDA) approval for one and two contiguous levels.

The Geneva, Switzerland-based company’s motion-preserving implant for cervical disc disease earned the agency nod based on two U.S. randomized controlled trials that enrolled almost 600 patients total. Company-cited clinical evidence also showed 85% of the implants maintained motion a decade following the procedure in a 10-year follow-up study published in the European Spine Journal.

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

The Baguera-C prosthesis treats damaged or diseases discs in the neck. Rather than fusing the bones together, it allows the spine to keep its natural movement. A core inside the disc moves slightly to reduce stress on the neck joints. Sloped titanium plates fit the cervical bones’ natural shape, and a coating on the plates helps to minimize interference during MRI scans.

Last March, the company won FDA 510(k) clearance for its PERLA App for use on eCential’s new Op.n robotic navigation platform. The PERLA App further integrates the Spineart PERLA TL Open and MIS screw systems with the eCential Op.n platform, offering navigation-specific interface and dedicated Spineart navigated instruments.