The European Union has granted CE Mark to K2M Group Holdings, Inc. for its Rhine cervical disc system.
According to a January 21, 2016 announcement, the disc is the company’s next-generation cervical artificial disc replacement featuring proprietary molding technology and is the company’s latest offering for the treatment of degenerative disc disease.
The disc system features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel. The proprietary molding technology is incorporated to “minimize wear between the polymer core and metal endplates.” The company says the system’s streamlined instrumentation simplifies the surgical technique by integrating trialing and keel cutting into one instrument. A built-in adjustable stop allows for customized anterior or posterior positioning of the disc based on surgeon preference.
Casey Lee, M.D., the principal inventor of the Rhine system, says the proprietary over-molding process of elastomeric polymer is what differentiates the system competing cervical disc systems. “We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe, ” added Lee.
Richard Guyer, M.D., co-founder of the Texas Back Institute, and director of the spine fellowship program in Roanoke, Texas, said, 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.”
According to the announcement, the first single- and multi-level surgical procedures using the system were recently completed in Belgium and Germany. Additionally, enrollment for a prospective, observational 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.
