Centinel Spine Receives First Cervical Multilevel Clearance

The FDA has just granted Centinel Spine, Inc., the first cervical multilevel indication for a stand-alone interbody device.

The company, the first to gain such clearance, announced in late June that its STALIF C and STALIF C-TITM now can be used on-label in multilevel, cervical spine fusion procedures. Company Chairman and CEO John Viscogliosi said the indication clearance from the FDA is valuable given the high incidence of multilevel degenerative disc disease in the cervical spine.

The STALIF C family of products was previously cleared by the FDA 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 clearance expands the on-label use to include the multilevel cervical spinal fusion procedures.

John Demakas, M.D. of the Rockwood Neuroscience Institute in Spokane, Washington, said as an integrated interbody, the dynamic capability of the STALIF C-Ti screws “allow the vertebral bodies to settle on 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.”

According to the company, the lag effect provides constant compressive forces against the implant which results “in a greater interface between the graft and the endplate to facilitate the fusion process.” The company also says the STALIF C screws are angled and biomechanically designed to direct axial forces along the long axis of the screws to “significantly reduce bending moments and preventing de-rotation of the screw and/or screw back-out.”

Centinel Spine is privately owned and began operations seven years ago. The company was created from a merger and acquisition of Raymedica LLC and Surgicraft LTD. The Viscogliosi’s mission is to make the company the leading anterior column support spine franchise.