Michael Barbella, Managing Editor03.14.24
Spineart SA has completed enrollment in its U.S. IDE trial comparing its BAGUERA C Cervical Disc Prosthesis with a commercially marketed cervical disc implant in patients with cervical disc disease at two contiguous levels between C3 and C7.
The multi-center, prospective, randomized controlled trial enrolled more than 300 patients at 25 U.S. sites. The study's primary endpoint is BAGUERA C's clinical success rate in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The company finished enrollment patients at the end of February.
"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," Spineart CEO Jerome Trividic said. "This unprecedented achievement underscores our commitment to advancing the adoption of 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."
The BAGUERA C Cervical Disc prosthesis is evaluated in two separate U.S. IDE trials 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. The implant is an investigational device designed to maintain or restore segmental motion and disc height in the spine's cervical region after single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA C is designed to maintain a spinal unit's natural behavior. Its 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 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," said Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, N.C., and co-lead investigator of the IDE trials.
Spineart aims to transform spine surgery for patients, surgeons, and hospitals by developing safe, efficient procedures and medical devices. Spineart is actively involved in disc prosthesis development, surgical simplification, 3D printed porous titanium, and surgical implant traceability. Today, Spineart has produced a 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.
The multi-center, prospective, randomized controlled trial enrolled more than 300 patients at 25 U.S. sites. The study's primary endpoint is BAGUERA C's clinical success rate in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The company finished enrollment patients at the end of February.
"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," Spineart CEO Jerome Trividic said. "This unprecedented achievement underscores our commitment to advancing the adoption of 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."
The BAGUERA C Cervical Disc prosthesis is evaluated in two separate U.S. IDE trials 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. The implant is an investigational device designed to maintain or restore segmental motion and disc height in the spine's cervical region after single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA C is designed to maintain a spinal unit's natural behavior. Its 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 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," said Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, N.C., and co-lead investigator of the IDE trials.
Spineart aims to transform spine surgery for patients, surgeons, and hospitals by developing safe, efficient procedures and medical devices. Spineart is actively involved in disc prosthesis development, surgical simplification, 3D printed porous titanium, and surgical implant traceability. Today, Spineart has produced a 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.