Centinel Spine today claimed it won the 1st multi-level indication for an interbody fusion device in the cervical spine, saying the FDA OK’d its Stalif C and Stalif C-Ti devices for then 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 1st company to receive this indication and to offer this benefit to our surgeon customers and their patients,” chairman & CEO John Viscogliosi said in prepared remarks. “This 1st-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.”
YY-based Centinel’s Stalif C was already cleared for cervical single-level fusion with autograft or allogeneic bone graft, the company said.
“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,” added Dr. John Demakas of the Rockwood Neuroscience Institute in Spokane, Wash. “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.”