MiRus wins FDA breakthrough nod for spine implant

MiRus announced that it received FDA breakthrough device designation for its Europa posterior cervical system for the spine.

The system, built on MiRus’ proprietary rhenium alloys, received the breakthrough designation for treating the cervical and upper thoracic spine. MiRus developed it around a 2.9 mm MoRe rod, which it says is much smaller than current commercial systems.

Europa’s lower-diameter rod allows for the use of low-profile pedicle screw tulips. This can lead to less invasive surgery and less hardware prominence in smaller patients. MiRus said its MoRe rods provide a superior level of rigidity, strength and fatigue resistance, despite its lower diameter. This reduces the risk of spine rod fractures compared to current systems.

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