K2M wins CE Mark for Rhine cervical disc

K2M (NSDQ:KTWO) said yesterday it won CE Mark approval in the European Union for its Rhine cervical disc system designed to treat degenerative disc disease.

The Leesburg, Va.-based company said the newly cleared device features a 1-piece compressible polymer core, dome-shaped, plasma-coated endplates and a central-split keel, formed through proprietary molding technology to minimize wear between the core and endplates

“The Rhine cervical disc system is manufactured through a proprietary over-molding process of elastomeric polymer that differentiates the system from the competitive offering. We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe,” Rhine system principal inventor Dr. Casey Lee said in a prepared statement.

The company said its newly released system integrates trialing and keel cutting into a single instrument, and has a built-in adjustable stop to allow for custom anterior or posterior positioning.

“The Rhine cervical disc system was developed through collaboration with a global surgeon design team. 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,” Dr. Richard Guyer of Roanoke, Texas’ Spine Fellowship Program said in a press release.

The 1st surgical procedures using the Rhine system were completed recently in Belgium and Germany, the company said. It plans to launch a 166-patient clinical study in the 1st quarter of 2016.

“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. 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,” CEO Eric Major said in prepared remarks.

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