Augmedics commenced U.S. launch of the xvision™ (XVS) augmented reality guidance system for spine surgery, following FDA 510(k) marketing clearance. The system is available for immediate sale, with headset distribution expected to begin early this year.
xvision Spine allows surgeons to visualize 3D spinal anatomy during surgery as if they had “x-ray vision,” and to navigate instruments and implants while looking directly at the patient, rather than a remote screen.
xvision comprises a transparent near-eye-display headset and all elements of traditional navigation. It determines the position of surgical tools in real time, then superimposes a virtual trajectory on the patient's CT data. 3D navigation data is then projected onto the surgeon’s retina using the headset, allowing a simultaneous view of the data and the patient. The system’s small footprint, economical cost, and compatibility with current instrumentation is designed to allow easy integration into any surgical facility.
In a percutaneous laboratory study, 93 screws were positioned in the thoracic and sacro-lumbar areas of five different cadavers. The study provided evidence to FDA to evaluate the accuracy of xvision Spine by comparing the actual screw tip position and trajectory vs. the virtual. Overall clinical accuracy, analyzed by two independent neuro-radiologists, was 98.9% using thoracic and lumbar scales.
“Augmedics’ mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow,” said Nissan Elimelech, Founder and CEO. “xvision is our first product of many to follow that will revolutionize surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow and help them do their jobs as effectively and safely as possible.”
Augmedics will explore additional applications for xvision beyond spinal surgery.