MiRus obtains US FDA Breakthrough Device Designation for spine implant, EUROPA PCF system

MiRus, a life sciences company based in Atlanta, Georgia, has received Breakthrough Device Designation from the FDA for its EUROPA Posterior Cervical System, which utilizes proprietary rhenium alloys for cervical and upper thoracic spine treatments.

The EUROPA PCF system features a 2.9 mm MoRe rod, significantly smaller than those in current commercial systems. This smaller rod allows for low-profile pedicle screw tulips, enabling less invasive surgeries with reduced hardware prominence, particularly in smaller patients. Despite its reduced size, the MoRe rod offers superior rigidity, strength, and fatigue resistance, minimizing the risk of spine rod fractures compared to existing systems.

MiRus is advancing the medical field by developing and commercializing innovative biomaterials and implants that enhance surgical outcomes by making procedures less invasive and implants safer and more durable.