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

News provided by

Feb 29, 2024, 06:00 ET

GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE 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 implant.

"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, chief executive officer 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."

Hyun W. Bae, MD, with the Spine Institute, Santa Monica, CA and one of the lead investigators for the study, said, "Cervical Disc Arthroplasty is becoming the preferred option in the treatment of degenerative disc disease as it allows to achieve decompression of the nerves, while preserving physiologic segmental motion. I am excited to continue following up my patients in the BAGUERA®C IDE study and confirming the initial positive outcomes we have collected so far."

The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.

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).

CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use.

ABOUT THE BAGUERA®C IDE CLINICAL TRIALS

The BAGUERA®C IDE trials, prospective, multi-center, randomized clinical studies, will evaluate the safety and efficacy of BAGUERA®C compared to the Mobi-C® cervical disc 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 (PMA) submission to the U. S. Food and Drug Administration.

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