MiRus Secures US FDA Breakthrough Device Designation for Spine Implant

MiRus, a company in the life sciences industry, has been granted Breakthrough Device Designation by the FDA for its EUROPA Posterior Cervical System, which uses its unique rhenium alloys, to treat issues in the cervical and upper thoracic spine.

The EUROPA PCF system features a 2.9 mm MoRe rod that is significantly smaller than existing commercial systems. The smaller size rod enables the use of low-profile pedicle screw tulips, which results in a more minimally invasive surgery and less prominence of hardware in smaller patients. Despite their smaller diameter, MoRe rods offer increased rigidity, strength, and fatigue resistance, leading to a lower likelihood of spine rod fractures when compared to existing 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 Orthopaedic 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."