MiRus has announced the FDA 510(k) clearance of the GALILEO spine alignment monitoring system, a non-optical, wireless, real-time measurement system for segmental and global sagittal spine alignment.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The GALILEO Spine Alignment Monitoring System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery navigation.
Eric Nottmeier, MD Neurosurgeon in Jacksonville, Florida stated “sagittal malalignment has been shown to directly impact the quality of life and function of patients. This innovative product will provide surgeons with much-needed real-time feedback for achieving optimal sagittal alignment in the OR.”
“Achieving spinal alignment correction in spinal deformity surgery is particularly challenging. For the first time, surgeons can now receive dynamic feedback as they perform corrective procedures and confirm that the planned sagittal alignment has been achieved,” said Thomas Morrison, MD, neurosurgeon at Polaris Spine & Neurosurgery, Atlanta, Ga.
Angad Singh, VP Robotics and Surgical Navigation commented “Given the increased attention to sagittal plane alignment in recent years, we are pleased to offer the first and only FDA-approved product that intraoperatively measures this important clinical parameter in real-time without reliance on repeated imaging.
The product is also an example of the kind of dynamic tracking and feedback we will be incorporating into our robotics platform.”
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.
Source: Company Press Release