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
pcowart@mirusmed.com
770-861-4804
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mirus-receives-breakthrough-device-designation-for-spine-implant-302211683.html
SOURCE MiRus