MiRus gets US FDA Breakthrough Device Designation for EUROPA PCF system- spine implant

MiRus, a life sciences company, has received FDA Breakthrough Device Designation for its EUROPA Posterior Cervical System, which uses proprietary rhenium alloys for cervical and upper thoracic spine treatments.

The system features a 2.9 mm MoRe rod, much smaller than current systems. This smaller rod enables the use of low-profile pedicle screw tulips, reducing invasiveness and hardware prominence in smaller patients. Despite its size, the MoRe rod offers high rigidity, strength, and fatigue resistance, decreasing the risk of rod fractures.

The EUROPA PCF system’s ultra-low profile and durable MoRe rod improve implant placement flexibility, enhancing fixation in complex cases. The reduced tulip volume also allows more room for the fusion bed, potentially boosting fusion rates.

With high rates of implant failures and revision surgeries, the EUROPA PCF system provides a more durable, less invasive solution for cervicothoracic patients. MiRus, based in Atlanta, develops novel biomaterials and implants to advance surgical techniques.