Centinel Spine, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbody fusion devices was granted the first cervical multilevel indication for a Stand-Alone interbody device by the U.S. Food and Drug Administration (FDA). STALIF C and STALIF C-TI™ now can 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. We are excited to be the first company to receive this indication and to offer this benefit to our surgeon customers and their patients," explained John J. Viscogliosi, Chairman & CEO, 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 MD, Rockwood Neuroscience Institute, Spokane, WA. "As an integrated interbody, the dynamic capability 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."
"This first-to-market indication is evidence that Centinel Spine will continue to be on the forefront of developing and enhancing spinal devices to meet the needs of our surgeon customers and their patients," Mr. Viscogliosi added.