US-based surgical implant company RTI Surgical has launched its MaxFuse vertebral body replacement system and the Aspect anterior cervical plate system.
RTI Surgical’s MaxFuse and Aspect systems, which are currently available for US distribution, are designed for use in spine fusion.
Made from Invibio’s Peek-Optima, the MaxFuse system is used to replace a diseased vertebral body, resected or excised for the treatment of tumors for achieving 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
Peek-Optima 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.
MaxFuse system allows surgeons to address a wide range of patient pathologies by offering 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.
The system obtained 510(k) approval from the US Food and Drug Administration (FDA) in December 2013.
Aspect system anterior cervical plate system is used for anterior cervical fixation for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities or curvatures, tumor, pseudoarthrosis and failed previous fusion indications.
The system is designed to meet the varying clinical needs of surgeons performing anterior cervical discectomy and fusion procedures. It temporarily provides resistance to flexion, extension, lateral bending and axial rotation with strength and stiffness in the cervical spine in order to support cervical fusion.
The system offers one through four-level plates, all with large graft visualization windows and a ‘zero-step’ locking mechanism. The self-drilling and self-tapping screw designs provide a quick start and excellent bone purchase.
The company obtained 510(k) clearance from the FDA for the Aspect system in June 2013.
RTI Surgical president and CEO Brian K Hutchison noted the MaxFuse VBR system and the Aspect anterior cervical plate system are two exciting new additions to our spine portfolio.
"These systems are manufactured in our world-class Marquette, Mich. facility and address important clinical needs in spine fusion," Hutchison added.