ATLANTA, Feb. 23, 2021 /PRNewswire/ -- MiRus
announced today that they will offer a LIFETIME LIMITED
WARRANTY on its Molybdenum-Rhenium ( MoRe®) superalloy rod
technology. The warranty will cover full replacement of the MoRe®
Rod and corresponding MiRus hardware used in spinal fusion cases
should the MoRe® Rod fracture. The warranty will cover all
thoracolumbar MoRe® rods implanted as part of the EUROPA™ Pedicle
Screw System supplied by MiRus in the
United States effective March
1, 2021.
The MoRe® Promise is a testament to Molybdenum-Rhenium's
dramatically superior mechanical and biological properties.
Jay Yadav, MD, Founder and CEO,
stated, "Because of our confidence in the science behind the MoRe®
alloy technology, MiRus is taking the extra step to warranty each
MoRe® rod implanted for the duration of the patient's life. This is
a testament to our belief in MoRe's dramatically superior
mechanical and biological properties."
MiRus is offering a lifetime limited warranty on MoRe® rods used
in posterior spinal fusions, a procedure that more than 700,000
patients suffering from back pain undergo each year in the
US.1 In complex spinal conditions research shows
an overall rate of rod fracture of 14.9% with approximately 63.6%
of patients requiring revision surgery.2 This poses a
significant cost to the patient and the healthcare system with the
costs of reoperation averaging $80,000, a 70% cost increase from initial
treatment.3 Additionally, more than one revision surgery
is often required, with each subsequent intervention becoming more
and more complex leading to a reported complication rate as high as
59%.4
Christopher Ames, MD Co-director,
Spinal Surgery and Spine Center Director, Spine Tumor and Spinal
Deformity Surgery at UCSF stated "solutions for preventing
revisions in complex adult spine surgery are key to assuring its
viability in the future under increasing cost
pressures. Despite the use of multiple rods composed of
titanium and cobalt we have still seen rod fractures.
Development and deployment of novel alloys and rod morphologies in
spine surgery is a valuable advance that hopefully will lower the
cost and improve the care of our patients. New alloys and shapes
along with PJF prevention, better understanding of alignment and
the host fusion substrate through predictive modeling and big data
will shape the future of complex long construct surgery."
The MoRe® PROMISE LIFETIME LIMITED WARRANTY program will fully
cover MoRe® Rod replacement and all associated EUROPA™ Pedicle
Screw System implant components required to treat any patient
undergoing a revision surgery should the MoRe® Rod fracture when
used per the instructions for use and in line with regulatory
approval.
Interested parties are encouraged to visit MiRus at
www.mirusmed.com/more-promise or contact the company for more
details about the MoRe® Promise LIFETIME LIMITED WARRANTY
program.
References:
- 2017 Spinal Surgery Update (2017) Orthopedic Network News, 28
(4), 1-28.
- Hamilton DK, Buza JA, Passias P, et al. The fate of patients
with adult spinal deformity incurring rod fracture after
thoracolumbar fusion. World Neurosurg 2017.
- McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of
surgical treatment for adult spinal deformity: an extended
follow-up study. Spine J. 2014
- Cho SK, Bridwell KH, Lenke LG, et al. Comparative analysis of
clinical outcome and complications in primary versus revision adult
scoliosis surgery. Spine (Phila. Pa. 1976). 2012
About MiRus, LLC.
MiRus is a medical device company
that has developed and is commercializing proprietary novel
biomaterials, implants and software solutions for spine,
orthopaedics and cardiovascular disease. We are addressing
the demands of today's healthcare environment with an integrated
platform of pre-operative planning and risk assessment tools, a
breakthrough navigation and post-operative monitoring and risk
mitigation. Find more information about MiRus at
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.
*MoRe® is a registered trademark of MiRus, LLC.
MiRus™ is a trademark of MiRus, LLC.
Contact:
Mahesh
Krishnan
Chief Commercial Officer
mkrishnan@mirusmed.com
770-317-5564
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SOURCE MiRus