Spineart announced completion of enrollment in its U.S. Investigational Device Exemption trial studying the Baguera C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc (Mobi-C, ZimVie)
Baguera C is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following one- or two-level discectomy for symptomatic cervical disc disease. Baguera C is designed to maintain the natural behavior of a functional spinal unit. This 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 Baguera C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of Baguera C compared to Mobi-C in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels in the cervical spine. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S. Results of this pivotal clinical trial will be the basis of a premarket approval submission to FDA.
Baguera C has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
“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.”
Spineart announced completion of enrollment in its U.S. Investigational Device Exemption trial studying the Baguera C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc (Mobi-C, ZimVie)
Baguera C is an investigational device designed to maintain or...
Spineart announced completion of enrollment in its U.S. Investigational Device Exemption trial studying the Baguera C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc (Mobi-C, ZimVie)
Baguera C is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following one- or two-level discectomy for symptomatic cervical disc disease. Baguera C is designed to maintain the natural behavior of a functional spinal unit. This 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 Baguera C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of Baguera C compared to Mobi-C in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels in the cervical spine. Each study will enroll approximately 300 subjects at up to 30 study sites in the U.S. Results of this pivotal clinical trial will be the basis of a premarket approval submission to FDA.
Baguera C has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
“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.”
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