MiRus received Breakthrough Device Designation from FDA for the EUROPA Posterior Cervical System, based on MiRus’ proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.
EUROPA PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial systems. The lower diameter rod allows low-profile pedicle screw tulips leading to less invasive surgery and less hardware prominence in smaller patients. Although lower diameter, MoRe rods provide a high level of rigidity, strength and fatigue resistance which reduces the risk of spine rod fractures compared to current systems.
“Currently the rates of spine implant failures and revision surgeries for patients remain unacceptably high,” commented Jordan Bauman, VP of Regulatory and Quality. “With EUROPA PCF, spine surgeons will be able to provide durable and less invasive surgery for their cervicothoracic patients. This is another step forward in our mission to provide less invasive and more durable devices across a broad spectrum of disease states.”
MiRus received Breakthrough Device Designation from FDA for the EUROPA Posterior Cervical System, based on MiRus' proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.
EUROPA PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial systems. The lower diameter rod allows...
MiRus received Breakthrough Device Designation from FDA for the EUROPA Posterior Cervical System, based on MiRus’ proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.
EUROPA PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial systems. The lower diameter rod allows low-profile pedicle screw tulips leading to less invasive surgery and less hardware prominence in smaller patients. Although lower diameter, MoRe rods provide a high level of rigidity, strength and fatigue resistance which reduces the risk of spine rod fractures compared to current systems.
“Currently the rates of spine implant failures and revision surgeries for patients remain unacceptably high,” commented Jordan Bauman, VP of Regulatory and Quality. “With EUROPA PCF, spine surgeons will be able to provide durable and less invasive surgery for their cervicothoracic patients. This is another step forward in our mission to provide less invasive and more durable devices across a broad spectrum of disease states.”
Copy to clipboard 
