Complex spine specialist K2M Group Holdings, Inc., says it has received a CE Mark for the RHINE™ Cervical Disc System which it describes as its next-generation cervical artificial disc replacement featuring proprietary molding technology.
Background
K2M designs, develops and commercializes innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies.
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 molding technology is incorporated to minimize wear between the polymer core and metal endplates.
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.
The first single- and multi-level surgical procedures using the RHINE Cervical Disc System were recently completed in Belgium and Germany. Additionally, enrollment for a prospective, observational RHINE Cervical Disc Clinical Study will begin in the first quarter of 2016. An estimated 166 participants are expected to be enrolled in the study at multiple clinical trial sites throughout Europe.
Developer comments
“The RHINE Cervical Disc System is manufactured through a proprietary over-molding process of elastomeric polymer that differentiates the system from the competitive offering,” said Dr. Casey Lee, Orthopedic 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.”
Physician comments
“The RHINE Cervical Disc System was developed through collaboration with a global surgeon design team,” said Dr. Richard Guyer, Orthopedic 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.”
Company comments
“We are excited to receive a CE Mark for our RHINE Cervical Disc technology, as it represents an important regulatory milestone event for K2M as we continue to build our product portfolio and penetrate the global spine market with innovative techniques and technologies,” stated Eric Major, K2M’s President and CEO. “We look forward to further expanding our international product offering and will remain focused on the complex spine category across all of our international markets.”
Source: Globe Newswire
published: January 22, 2016 in: Approval/Clearance, Spine