Spineart Gains IDE Approval for BAGUERA C Trial

By Julie A. Vetalice

Spineart Gains IDE Approval for BAGUERA C Trial

Spineart received Investigational Device Exemption (IDE) approval from FDA to initiate a clinical trial of the BAGUERA® C Cervical Disc Prosthesis. The single-level trial compares BAGUERA C to another FDA approved arthroplasty device at up to 30 centers across the U.S.

BAGUERA C is an MRI compatible disc. Anatomically shaped endplates accommodate patient anatomy and minimize vertebral endplate manipulation. The inner layers of the endplates feature a diamond-like-coating to minimize wear. A load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels.

In 2016, two-year study results indicated that patients treated with the BAGUERA C cervical disc in 1- or 2-level arthroplasty exhibited good mobility at treated and adjacent levels, disc height restoration and evidence of adjacent level preservation.

Jerome Trividic, President of Spineart USA, said, “Thanks to a fruitful collaboration with the FDA, we will be starting patient enrollment in the upcoming months. We are excited to bring BAGUERA C to the United States, after more than a decade of successful patient outcomes outside the U.S."

Product Labels: Cervical Spine, Spine Artificial Disc

Tags: Trial/Study