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HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA100th U.S. Patient Treated In IDE Clinical Trials Of Baguera® C Cervical...

100th U.S. Patient Treated In IDE Clinical Trials Of Baguera® C Cervical Disc Prosthesis

Spineart USA Inc. announced today that the 100th surgery has been performed in their combined single-level and two-level U.S. Investigational Device Exemption (IDE) Clinical Trials of the BAGUERA® C Cervical Disc Prosthesis.

Dr. Armen Khachatryan at The Disc Replacement Center, in Salt Lake City, UT, is currently the leading enroller for the single-level trial, and Dr. Hyun Bae at the Foundation for Spinal Restoration in Santa Monica, CA, is the leading enroller for the two-level trial. The BAGUERA® C implant is an investigational device designed to reconstruct the cervical disc following discectomy for symptomatic cervical disc disease.

Surgery to treat cervical degenerative disc disease is generally considered when neurological symptoms are present, such as persistent arm numbness and/or weakness, or when chronic pain is severe and not adequately relieved after at least six months of non-surgical treatments, and daily activities become difficult. Artificial cervical disc replacement involves the removal of the problematic disc and replaces it with an artificial prosthesis. The goal of this surgery is to restore the height and preserve motion at that spinal level.

Dr. Armen Khachatryan, commented, “As part of the FDA IDE study, we implanted one single-level and two two-level patients with BAGUERA discs in an outpatient setting last week. Similar to most anterior cervical procedures, all three patients reported positive relief of symptoms in the recovery room and were discharged within a few hours.”

Clinical study can be found here.

ABOUT THE 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).

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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