Spineart Finishes Enrollment in Baguera C IDE Trial

Spineart has finished enrollment in its U.S. investigational device exemption (IDE) trial evaluating its Baguera C cervical disc prosthesis for single-level cervical disease between C3 and C7. The trial will compare treatment with Baguera C to a commercially marketed cervical disc implant.
 
The investigational Baguera C was designed to maintain or restore segmental motion and disc height in the cervical spine following single- or two-level discectomy for symptomatic cervical disc disease. It aims to maintain a functional spinal unit’s natural behavior.
 
The Baguera C nucleus moves in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) and independent translational motions (anterior-posterior and lateral translations).
 
Hyun W. Bae, MD, with the Spine Institute, Santa Monica, Calif. and one of the lead investigators for the study, said, “Cervical Disc Arthroplasty is becoming the preferred option in the treatment of degenerative disc disease as it allows to achieve decompression of the nerves, while preserving physiologic segmental motion. I am excited to continue following up my patients in the BAGUERA C IDE study and confirming the initial positive outcomes we have collected so far.”
 
The technology has been available in Europe and worldwide markets since 2008, with over 60,000 implants sold, according to Spineart.
 
“We would like to thank all the investigators, their staff and the patients participating in the BAGUERA C trial for their dedication and support,” said Jerome Trividic, CEO of Spineart. “We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA C as a leading motion preserving technology for US surgeons and their patients.”
 
In January 2023, Spineart began a partnership with eCential Robotics to co-develop spine surgery applications and co-market eCential’s open robotic surgery platform.