Centinel Spine has been granted clearance by the US Food and Drug Administration (FDA) for its STALIFMidline, Midline II and Midline II-Ti (Ti-Active) devices for use with allogeneic bone graft in lumbar spinal fusion procedures.
All of Centinel Spine’s stand-alone, no-profile, integrated interbody systems are indicated for use with both autograft and/or allogeneic bone graft in lumbar and cervical spinal fusion procedures. Both STALIF C and STALIF C-Ti, used in anterior cervical discectomy and fusion (ACDF) procedures, received their allogeneic clearance in late 2014.
“Surgeons can feel confident that if they choose allogeneic tissue or autograft bone they are using all our integrated interbody devices on-label in either anterior cervical or anterior lumbar spinal fusion (ALIF) procedures,” said John J Viscogliosi, chairman and chief executive officer of Centinel Spine.
This new indication was FDA cleared in addition to the current lumbar products’ existing clearance. Centinel Spine developed Midline II to strike a balance between historical, clinical success and new surgeon-driven features and benefits to evolve to the next generation of Integrated Interbody devices.
Jon I White, Irvine Orthopaedic Associates, Irvine, USA, commented, “In my practice, I prefer to use Midline II for my anterior spinal fusion procedures as it provides the best stability and offers many unique features. The new allogeneic indication gives me additional peace of mind that I am providing the best care for my patients. In my opinion, Midline II is the safest and easiest product to use.”
Centinel Spine also says that Midline II also provides the STALIF benefits of compressive fixation with the horizontal inclination of it lag screws. “My patients have great clinical outcomes and are pleased that their surgery can be performed standalone, from the front only” continued White.