Spineart USA announced completion of the first surgery in the two-level U.S. Investigational Device Exemption clinical trial of the BAGUERA®C Cervical Disc.
BAGUERA C is an investigational device designed to restore height and preserve motion at that spinal level. The disc design enables the BAGUERA C nucleus to move in all six degrees of freedom, with independent angular rotations and translational motions.
The prospective, multi-center, randomized clinical studies will compare BAGUERA C to the Mobi-C® cervical disc (Zimmer Biomet) in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S.
Jerome Trividic, President of Spineart USA, said, "The enrollment of the first patient in our BAGUERA®C two-level trial is an important achievement made possible by the relentless work of our employees and partner surgeons. We have embarked on an ambitious project to gather additional solid scientific evidence of safety and effectiveness for our BAGUERA®C artificial disc with the ultimate goal of providing spine surgeons in the United States and their patients with new treatment options."