Centinel Spine has been granted the first cervical multilevel indication for a stand-alone interbody device by the US Food and Drug Administration (FDA). Stalif C and Stalif C-Ti can now be used on-label in multilevel, cervical spine fusion procedures.
“This is a valuable indication given the high incidence of multilevel degenerative disc disease in the cervical spine,” explained John J Viscogliosi, chairman and chief executive officer, Centinel Spine.
The Stalif C product family had been previously cleared for use in conjunction with autograft or allogeneic bone graft at a single level in patients with degenerative disc disease of the cervical spine. The new FDA clearance expands the original Stalif C and Stalif C-Ti indication to include multilevel cervical spinal fusion procedures.
“The FDA clearance provides both surgeons and patients with the assurance that Stalif C and Stalif C-Ti can be safely used to treat multilevel cervical spine pathologies,” said John Demakas, Rockwood Neuroscience Institute, Spokane, USA. “As an integrated interbody, the dynamic capabilities of the Stalif C-Ti screws allow the vertebral bodies to settle onto to the graft site. Combine this with compressive lag fixation and the osteoconductive advantage of the titanium coating, and Stalif C-Ti gives my patients the best opportunity for a solid fusion.”