GENEVA, Feb. 29, 2024 /PRNewswire/ — Spineart SA, producer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial finding out the BAGUERA®C Cervical Disc Prosthesis in sufferers with single-level cervical disc illness between C3 to C7 in comparison with a commercially marketed cervical disc implant.
“We wish to thank all of the investigators, their workers and the sufferers taking part within the BAGUERA®C trial for his or her dedication and assist,” mentioned Jerome Trividic, chief govt officer of Spineart. “We’re dedicated to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a number one movement preserving know-how for US surgeons and their sufferers.”
Hyun W. Bae, MD, with the Backbone Institute, Santa Monica, CA and one of many lead investigators for the examine, mentioned, “Cervical Disc Arthroplasty is turning into the popular choice within the remedy of degenerative disc illness because it permits to realize decompression of the nerves, whereas preserving physiologic segmental movement. I’m excited to proceed following up my sufferers within the BAGUERA®C IDE examine and confirming the preliminary optimistic outcomes we now have collected up to now.”
The BAGUERA®C Cervical Disc Prosthesis has been commercially accessible in chosen European and worldwide markets since 2008 with over 60,000 implants offered.
BAGUERA®C CERVICAL DISC PROSTHESIS
The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational gadget designed to keep up or restore segmental movement and disc peak within the cervical area of the spine following single- or two-level discectomy for symptomatic cervical disc illness. The BAGUERA®C is designed to keep up the pure conduct of a practical spinal unit. This design allows the BAGUERA®C nucleus to maneuver in all six levels of freedom, with unbiased angular rotations (flexion-extension, lateral bending, and axial rotation) together with unbiased translational motions (anterior-posterior and lateral translations).
CAUTION: Investigational Gadget. Restricted by Federal (United States) legislation to investigational use.
ABOUT THE BAGUERA®C IDE CLINICAL TRIALS
The BAGUERA®C IDE trials, potential, multi-center, randomized scientific research, will consider the security and efficacy of BAGUERA®C in comparison with the Mobi-C® cervical disc within the remedy of symptomatic cervical disc illness at a single- or two contiguous ranges within the cervical spine. Every examine will enroll roughly 300 topics at as much as 30 examine websites within the U.S. Outcomes of this pivotal scientific trial would be the foundation of a premarket approval (PMA) submission to the U. S. Food and Drug Administration.
SPINEART
Spineart’s mission is to remodel spine surgical procedure for sufferers, surgeons, and hospitals by growing procedures and medical units which can be secure and environment friendly, utilized by surgeons to boost their affected person’s life. True to its values: High quality, Innovation, Simplicity, Spineart is famend as a pioneer within the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants. Immediately, Spineart stays on the forefront of its sector with the event of a whole portfolio of procedural options and digital applied sciences for surgical help. Spineart was awarded the “Prix de l’Economie Genevoise 2022” for its contribution to technological and scientific improvements, business actions, job creations and ESG rules. Please go to www.spineart.com and comply with us on Linkedin (Spineart)
SOURCE Spineart
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