Interim data on Spineart’s Baguera-C cervical disc shows the device meets the threshold for a non-inferiority claim compared to a study control, the medtech company said March 11.
Spineart plans to submit premarket approval for the disc in August, according to a news release. The disc’s nucleus can move in all six degrees of freedom with independent angular rotations and independent translational motions.
The investigational device exemption trial is assessing the Baguera-C disc for single-level disc replacement compared to the Mobi-C disc for symptomatic cervical disease. It spans 25 U.S. sites and includes 285 patients.
