First-in-Man, 1- and 2-Level Cervical Disc IDE Study
Dom Coric, M.D., principal investigator for Spineart USA Inc.’s BAGUERA C Cervice Disc Prosthesis IDE [investigational device exemption] study and member of Carolina Neurosurgery and Spine Associates and Spine Division Chief at Atrium Musculoskeletal Institute in Charlotte, North Carolina, performed the first-in-man two-level surgery for the new device.
According to the study sponsor, Spineart, the BAGUERA C is “designed to reconstruct the cervical disc after two-level discectomy at adjacent segments for symptomatic cervical disc disease.” In addition to a first-in-man two-level implant, the company also announced first-in-man single-level implant.
The surgeries are part of a single-level AND a two-level U.S. Investigational Device Exemption Clinical Trial of the BAGUERA C Cervical Disc Prosthesis.
BAGUERA C is designed such that the nucleus can move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) and independent translational motions (anterior-posterior and lateral translations).
Byron Branch, M.D. of Carolina Neurosurgery and Spine Associates in Charlotte, North Carolina, performd the single-level procedure. “The BAGUERA C cervical disc is an innovative device with a simple yet reliable technique,” said Dr. Branch.
“The BAGUERA C cervical disc is a modern generation artificial disc and the application technique is straightforward compared to other devices I have used. I am excited to continue enrolling more patients in this study and to start collecting outcome data,” said Dr. Coric.
When OTW asked for details on the product, Spineart USA President Jerome Trividic commented, “BAGUERA C is an artificial disc prosthesis consisting of two titanium endplates with a diamond-like carbon coating articulating around a high-density polyethylene core. These characteristics combine durability with post-operative imaging compatibility. The anatomical profile and ‘no-keel’ design of the prosthesis, pre-mounted on a radiolucent holder, simplifies and reduces the surgical steps.”
And what will the next few months hold for BAGUERA C?
“We have made great progress with building up our clinical operations infrastructure and initiating clinical sites,” Trividic told OTW. “Our focus over the next few months remains on adding additional sites throughout the country, while at the same time, accelerating patient enrollment for both studies.”