RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today the full market launch of the MaxFuse ™ Vertebral Body Replacement System and the Aspect® Anterior Cervical Plate System. Both systems are designed for use in spine fusion and are currently available for U.S. distribution.
“The MaxFuse VBR System and the Aspect Anterior Cervical Plate System are two exciting new additions to our spine portfolio,” said Brian K. Hutchison, RTI Surgical president and chief executive officer. “These systems are manufactured in our world-class Marquette, Mich. facility and address important clinical needs in spine fusion.”
MaxFuse VBR System
The MaxFuse System is used to replace a diseased vertebral body, resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues in the thoracolumbar spine. The device also aids in restoring the height of a collapsed vertebral body. The system is made from PEEK-OPTIMA ®, a unique material selected for its strength, which helps maximize the volume of bone graft that can be placed inside the implant, as well as the graft-endplate apposition which supports the goal of a solid fusion.The system allows surgeons to address a wide range of patient pathologies by offering industry-leading size options in footprints and heights and is designed to optimize fit with the adjacent vertebral bodies, as well as to restore a more normal sagittal balance. RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in December 2013. Aspect Anterior Cervical Plate System The Aspect System is a simple, yet versatile anterior cervical plate system designed to meet the varying clinical needs of surgeons performing Anterior Cervical Discectomy and Fusion (ACDF) procedures. The system is used for anterior cervical fixation for degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures, tumor, pseudoarthrosis and failed previous fusion indications. RTI received 510(k) clearance from the FDA for the Aspect system in June 2013.