Spineart USA announced that the 100th surgery has been performed in their combined single-level and two-level U.S. Investigational Device Exemption (IDE) clinical trial of the BAGUERA® C Cervical Disc Prosthesis. BAGUERA C is an investigational device designed to reconstruct the cervical disc following discectomy for symptomatic cervical disc disease.
Surgery to treat cervical degenerative disc disease is generally considered when neurological symptoms are present, such as persistent arm numbness and/or weakness, or when chronic pain is severe and not adequately relieved after at least six months of non-surgical treatments, and daily activities become difficult. Artificial cervical disc replacement involves the removal of the problematic disc and replaces it with an artificial prosthesis. The goal of this surgery is to restore the height and preserve motion at that spinal level.
BAGUERA C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations).
The BAGUERA C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of BAGUERA C compared to the Mobi-C® cervical disc (Zimmer Biomet) in the treatment of symptomatic cervical disc disease at a single or two contiguous levels in the cervical spine. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S. Results of this pivotal clinical trial will be the basis of a premarket approval submission to FDA.