SPINEART COMPLETES ENROLLMENT IN THE BAGUERA®C IDE TRIAL FOR TWO-LEVEL CERVICAL DISC REPLACEMENT

2024-03-08

临床研究

GENEVA, March 8, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant.

The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024.

Jerome Trividic, CEO of Spineart, said, "The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart's ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States. This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition."

Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, "The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features."

The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.

BAGUERA®C CERVICAL DISC PROSTHESIS

The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The 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).

SPINEART

Spineart's mission is to transform spine surgery for patients, surgeons, and hospitals by developing procedures and medical devices that are safe and efficient, used by surgeons to enhance their patient's life. True to its values: Quality, Innovation, Simplicity, Spineart is renowned as a pioneer in the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants. Today, Spineart remains at the forefront of its sector with the development of a complete portfolio of procedural solutions and digital technologies for surgical assistance. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles. Please visit www.spineart.com and follow us on Linkedin (Spineart)

SOURCE Spineart