MiRus has announced that it received US Food and Drug Administration (FDA) 510(k) clearance for its 3DR (randomised) printed lumbar interbody fusion system which consists of the Callisto 3DR PLIF, Hyperion 3DR TLIF, Calypso 3DR LLIF and the Antares 3DR ALIF devices.
“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, orthopaedic surgeon at OrthoNortheast, Fort Wayne, USA.
After using the new Hyperion TLIF interbody, James Mok orthopaedic spine surgeon with Dupage Medical Group, Elmhurst, USA 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 [minimally invasive surgery] 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, associate professor, Emory University Department of Neurosurgery, Atlanta, USA observed: “The unique open structure modelled 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 visualisation.”
Jay S Yadav, founder and CEO of MiRus, said: “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 randomised lattice structure that mimics the organic structure of bone, sets the benchmark for matching the stiffness and porosity of cancellous bone.”