BAGUERA® C in the US – Investigational Device Exemption (IDE) FDA Approval

Spineart is pleased to announce that it has received Investigational Device Exemption (IDE) approval from the FDA to initiate a clinical trial to determine the safety and effectiveness of the BAGUERA® C Cervical Disc Prothesis. The single-level trial will compare the BAGUERA® C Cervical Disc Prothesis to another FDA approved arthroplasty device and will take place in up to 30 centers across the United States.

 

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 US”. 

 

BAGUERA® C Cervical Disc Prosthesis

The BAGUERA® C Cervical Disc Prosthesis is an MRI compatible disc. The endplates of the BAGUERA® C are anatomically shaped, to accommodate the patient anatomy and to minimize vertebral endplate manipulation. The inner layer of the prosthesis’ endplates are coated with a diamond-like-coating to minimize wear. The load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels.