MiRus Receives Breakthrough Device Designation for Spine Implant

ATLANTA, July 31, 2024 /PRNewswire/ -- 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."

About MiRus, LLC.
MiRus is a life sciences company headquartered in Atlanta, Georgia that has developed and is commercializing proprietary novel biomaterials and implants that are transforming medicine by making surgeries less invasive and implants safer and more durable. www.mirusmed.com. 

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The EUROPA^® Posterior Cervical System is not FDA approved.

* MiRus^® , EUROPA^®, MoRe^®  are all trademarks of MiRus, LLC. 

Contact:
Pam Cowart
VP of Clinical Affairs
[email protected]
770-861-4804

SOURCE MiRus