ATLANTA — February 22, 2021—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.
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.