K2M's RHINE™ Cervical Disc received approval under the CE Mark.
RHINE comprises a 1-piece compressible polymer core with dome-shaped, plasma-coated metal endplates and a central-split keel, and is manufactured with a proprietary overmolding process intended to minimize wear between the core and endplates.
Initial single- and multi-level procedures have been completed in the EU, where enrollment for a 166-patient prospective, observational clinical study will begin in 1Q16.
Source: K2M, Inc.
In its 3Q15 revenue call, K2M affirmed that it intends to target ex-U.S. markets initially to gauge performance and interest in the RHINE disc.
The EU trial is an open label, multi-center study of patients requiring surgical treatment at one or two contiguous cervical levels. Primary objectives are to:
- obtain operative data and feedback on surgical instruments and surgical technique
- confirm device performance in terms of clinical and radiographic outcomes
- confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.
ORTHOWORLD estimates placed the 2013 artificial disc replacement market at a 3% share of the global spine market (excluding biologics). Of that, cervical discs accounted for 70%. (Source: CERVICAL AND LUMBAR ARTIFICIAL DISC PROFILES, October 2014)