Spineart completed enrollment in its U.S. IDE trial studying the BAGUERA-C Cervical Disc Prosthesis in patients with cervical disc disease.
The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint 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.
The BAGUERA-C implant has been commercially available in select European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.
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.”
Spineart completed enrollment in its U.S. IDE trial studying the BAGUERA-C Cervical Disc Prosthesis in patients with cervical disc disease.
The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint is the clinical success rate of BAGUERA-C in two contiguous...
Spineart completed enrollment in its U.S. IDE trial studying the BAGUERA-C Cervical Disc Prosthesis in patients with cervical disc disease.
The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint 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.
The BAGUERA-C implant has been commercially available in select European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.
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.”
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