K2M has been granted CE marking for the Rhine cervical disc system, which can now be sold and distributed within Europe. This device is a next-generation artificial disc replacement intended for the treatment of degenerative disc disease.
The Rhine cervical disc system features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel. Proprietary moulding technology is incorporated to minimise wear between the polymer core and metal endplates.
“The Rhine cervical disc system is manufactured through a proprietary over-moulding process of elastomeric polymer that differentiates the system from the competitive offering,” says Casey Lee, orthopaedic surgeon and principal inventor of the Rhine cervical disc system. “We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe.”
The system’s streamlined instrumentation is designed to simplify the surgical technique by integrating trialling and keel cutting into one instrument. A built-in adjustable stop should allow for customised anterior or posterior positioning of the disc based on surgeon preference.
“The Rhine cervical disc system was developed through collaboration with a global surgeon design team,” says Richard Guyer, orthopaedic surgeon, co-founder of the Texas Back Institute, and Director of the Spine Fellowship Program in Roanoke, Texas. “The one-piece compressible polymer core design performed well in biomechanical testing when compared to the natural cervical disc, and this European launch represents evolution in cervical disc technology.”
The first single- and multi-level surgical procedures using the Rhine cervical disc system were recently completed in Belgium and Germany. Additionally, enrolment for a prospective, observational Rhine cervical disc clinical study will begin in the first quarter of 2016. Primary objectives of the study are to obtain operative data and feedback, confirm device performance, and collect radiographic data and clinical outcomes. An estimated 166 participants are expected to be enrolled in the study at multiple clinical trial sites throughout Europe.