FDA Clears First Real-Time Spine Alignment Monitoring System

The FDA has 510(k) cleared the Atlanta, Georgia-based MiRus, LLC’s GALILEO™ Spine Alignment Monitoring System.

The monitoring system provides real-time measurement and monitoring of segmental and/or global spine alignment without repeated imaging.

Company VP Angad Singh, said in a July 22, 2019 press release that this was the first and only FDA-cleared product that “intraoperatively measures this important clinical parameter in real-time without reliance on repeated imaging.”

According to June 17, 2019 FDA clearance documents, the system is intended to, “provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.”

Further, the system is indicated “for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy.”

Here’s how it works.

The system uses disposable, miniaturized sensors and advanced sensor fusion algorithms to measure vertebral and spinal alignment in the sagittal plane.

Orientation and Sensing Modules (OSM) are attached to a patients’ vertebrae in a prone position. The battery powered OSMs contain inertial sensors that measure the alignment changes and wirelessly send the data to a computer.

The computer software, according to the FDA documents, then calculates sagittal plane spinal alignment parameters, “in real-time based on the OSM measurements and displays the information on a touch screen tablet.”

Thomas Morrison, M.D., a neurosurgeon at Atlanta’s Polaris Spine and Neurosurgery, said, “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.”

The technology impressed eight independent surgeon judges enough to name the system as a recipient as one of OTW’s 2018 Best New Spine Technologies Awards.