PRNewswire06.11.20
MiRus has 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," said Alan McGee MD, orthopedic surgeon at OrthoNortheast in Fort Wayne, Indiana.
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."
Jay S. Yadav MD, Founder and CEO of MiRus, added, "We have collaborated with an outstanding group of orthopedic 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."
"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," said Alan McGee MD, orthopedic surgeon at OrthoNortheast in Fort Wayne, Indiana.
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."
Jay S. Yadav MD, Founder and CEO of MiRus, added, "We have collaborated with an outstanding group of orthopedic 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."