ATLANTA — June 11, 2020—MiRus is pleased to announce that it received FDA 510(k) clearance for its 3DR™ (Randomized) Printed Lumbar Interbody Fusion System which consists of the CALLISTO 3DR™ PLIF, HYPERION 3DR™ TLIF, CALYPSO 3DR™ LLIF and the ANTARES 3DR™ ALIF.
“The HYPERION 3DR TLIF is the first interbody with stiffness equivalent to cancellous bone, providing improved load sharing, reduced risk of subsidence and potentially superior fusion rates.” noted Alan McGee MD, Orthopaedic Surgeon at OrthoNortheast in Fort Wayne, Indiana
MiRus currently leads the industry in innovative clinical solutions with the smallest pedicle screws, lowest profile cervical plate, and a real-time intra-operative sagittal alignment system. With the launch of the 3DR™ Interbody System, MiRus has set the benchmark for interbodies with a stiffness of 0.53 GPa, the lowest stiffness of any interbody in the world and in the same range as cancellous bone.
After using the new Hyperion TLIF interbody, James Mok, MD, MBA, Orthopedic Spine Surgeon with Dupage Medical Group, Elmhurst, IL noted “the interbody has the unique combination of a big graft window, which I consider important in order to allow bridging bone that can be evaluated on x-ray, combined with the benefits of 3D printing to mimic normal bone architecture and in-growth. My practice is almost exclusively MIS and in combination with the smallest profile pedicle screws from MiRus, I am excited to have these PLIF and TLIF interbodies available because of their handling characteristics and x-ray appearance.”
Faiz Ahmad MD, Associate Professor, Emory University Department of Neurosurgery, Atlanta observed “The unique open structure modeled after the cancellous bone promotes bony on-growth and in-growth as well as providing the largest graft volume of any interbody on the market. I am also impressed with the low radio-density of the interbody allowing for easy postoperative visualization.”
Jay S. Yadav MD, Founder and CEO of MiRus, stated “We have collaborated with an outstanding group of orthopaedic and neurosurgeons to develop transformative interbody solutions. With the shift in the market to 3D printed interbodies, the MiRus 3DR™ Printed Lumbar Interbody Fusion System designed with a randomized lattice structure that mimics the organic structure of bone, sets the benchmark for matching the stiffness and porosity of cancellous bone. ”
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 robotics system 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.
* CALLISTO 3DR™, CALYPSO 3DR™, HYPERION 3DR™, ANTARES 3DR™ and MiRus™ are trademarks of MiRus, LLC.