Centinel Spine, Inc., (Centinel Spine) announces the U.S. Food and Drug Administration (FDA) clearance of ALTOS™, a posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine. The first surgical implantation of the ALTOS system was performed by Gery Hsu, MD, CRMC Medical Associates, Coffeyville, KS on January 4, 2016.
"Centinel Spine is dedicated to developing products that address surgical needs, anatomical challenges and surgeon requirements," said John J. Viscogliosi, Chairman & CEO, Centinel Spine. "We look forward to seeing the successful clinical outcomes and evidence that ALTOS was designed to achieve," Mr. Viscogliosi continued.
ALTOS is the first FDA cleared posterior cervical thoracic system specifically designed for implantation into either the cervical lateral masses or the cervical-thoracic pedicles. This low profile, stabilization system offers both fully threaded and smooth shank polyaxial screws with 80 degrees of freedom for simple insertion in the most demanding spinal anatomies. The system also provides laminar hooks, connectors, straight and curved rods for customizable constructs that meet each patient's anatomical needs to provide outstanding clinical outcomes.
Jason E. Garber, MD, FACS, Western Regional Center for Brain & Spine Surgery, Las Vegas, NV, explained, "ALTOS is a comprehensive system that was designed to provide the surgical versatility needed to address posterior cervical spinal pathologies. The low profile system is simple to insert minimizing patient trauma and surgical time. It can also be easily customized to successfully address many patients' degenerative pathologies."
In addition to ALTOS, Centinel Spine also develops, manufactures, markets and sells the complete STALIF® product family, which includes STALIF C®, STALIF C-Ti™, MIDLINE II™ and MIDLINE II-Ti™. STALIF C-Ti and MIDLINE II-Ti merge the proven clinical success of STALIF Integrated Interbody technology with Ti-ACTIVE™, a titanium coating engineered with over 15 years of science and experience to produce an optimized, surface topography enabling cellular proliferation.1, 2, 3, 4
"We are proud to deliver the ALTOS system, Ti-ACTIVE technology and STALIF product families to patients around the world," explained Mr. Viscogliosi. "The ALTOS system exemplifies our commitment to advancing the standard of care in spinal fusion procedures with our clinically proven technologies."