MiRus has received FDA Priority Device Designation for its EUROPA® Posterior Cervical System, which utilizes proprietary rhenium alloys to treat the cervical and upper thoracic spine.
The EUROPA® PCF system features a 2.9 mm MoRe rod, significantly smaller than those used in current commercial systems. This reduced diameter allows for the use of low-profile pedicle screw tulips, resulting in less invasive procedures and decreased hardware visibility in smaller patients.
Despite their smaller size, MoRe rods provide enhanced rigidity, strength, and fatigue resistance, reducing the risk of spine rod fractures compared to existing systems. The EUROPA® PCF system also offers greater flexibility in implant placement, which was not achievable with previous systems.
This enhanced flexibility improves fixation in complex cases, while the reduced tulip volume allows for more space in the fusion bed, potentially increasing fusion rates in patients.
With the EUROPA® PCF system, spine surgeons can perform more durable and less invasive procedures for cervicothoracic patients. This advancement marks significant progress in delivering less invasive and more resilient devices for a wide range of medical conditions.
Source: https://www.mirusmed.com/mirus-receives-breakthrough-device-designation-for-spine-implant/
