MiRus has received Breakthrough Device Designation from the FDA for the EUROPA Posterior Cervical System, based on it’s proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.
The 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 superior level of rigidity, strength, and fatigue resistance which reduces the risk of spine rod fractures compared to current systems.
“I have used the 4.5mm MoRe rod TL system for complex cases and have had good results,” stated Han Jo Kim MD, Professor of Orthopedic Surgery at the Hospital for Special Surgery, New York. “There is tremendous potential in what this proprietary alloy (MoRe) can accomplish in spine surgery, offering implants that are lower profile, more durable and stronger.”
Dr. Ankit Mehta, Associate Professor of Neurosurgery and Chief of Spine at University of Illinois Chicago commented, “The ultra-low profile EUROPA PCF system combined with the durability of the 2.9mm MoRe rod allows for flexibility in placing implants that previously could not be achieved, allowing for better fixation in these complicated cases. Lower tulip volume means more room for the fusion bed thereby enhancing fusion rates in patients.”
“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.”
