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.
“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 develops proprietary novel biomaterials and implants aimed at transforming medicine. The company wants to make surgeries less invasive and implants safer and more durable. The company recently announced first-in-human data for its TAVR implant made from its proprietary alloys.
