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.
About 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
About SpineArt
Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment. Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.http://www.spineart.com