Following the recent FDA approval to initiate a pivotal IDE clinical study for the BAGUERA® C artificial cervical disc at 1-level, Spineart is proud to announce that it has received approval from the FDA to initiate as well a pivotal IDE clinical study for BAGUERA® C at two contiguous levels.
Both studies will be randomized controlled trials comparing the BAGUERA® C artificial cervical disc to another FDA approved arthroplasty device and they will take place simultaneously at up to 30 centers across the country.
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 and the inner layers are coated with a diamond-like material that features a low coefficient of friction. The load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels
Caution Investigational Device, Limited by Federal (or United States) Law to Investigational Use