MiRus Receives Breakthrough Device Designation for Spine Implant
Anthony Jackson
Connecting Medical Device Professionals | Non-Executive Board Member
MiRus® have announced that their EUROPA® Posterior Cervical System has been granted Breakthrough Device Designation by the FDA. This designation recognizes the innovative use of MiRus's proprietary rhenium alloys in treating conditions of the cervical and upper thoracic spine.
The EUROPA® PCF system features a 2.9 mm MoRe rod, significantly smaller than those found in current commercial systems. This reduced diameter facilitates the use of low-profile pedicle screw tulips, resulting in less invasive surgeries and decreased prominence of hardware, particularly beneficial for smaller patients. Despite its smaller size, the MoRe rods offer superior rigidity, strength, and resistance to fatigue, thereby lowering the risk of spine rod fractures compared to existing systems.
"I've utilized the 4.5mm MoRe rod TL system in complex cases with excellent outcomes," said , Han Jo Kim Professor of Orthopedic Surgery at the Hospital for Special Surgery, New York. "The potential of this proprietary MoRe alloy in spine surgery is tremendous, providing implants that are not only more durable and stronger but also lower in profile."
Ankit Mehta, MD, FAANS, FACS Associate Professor of Neurosurgery and Chief of Spine at the University of Illinois Chicago, added, "The EUROPA® PCF system's ultra-low profile, combined with the durability of the 2.9mm MoRe rod, offers increased flexibility in implant placement previously unattainable. This advancement allows for better fixation in complex cases, potentially enhancing fusion rates by optimizing the fusion bed."
Jordan Bauman , VP of Regulatory and Quality at MiRus, commented on current challenges in spine surgery: "Current rates of spine implant failures and subsequent revision surgeries are unacceptably high. The EUROPA® PCF system represents a significant advancement, enabling spine surgeons to perform more durable and minimally invasive surgeries for their cervicothoracic patients. This marks another stride in our commitment to delivering less invasive and more durable medical devices across various disease states."