December 23, 2019 – Augmedics, creators of augmented reality (AR) surgical image guidance systems, has today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its xvision Spine system (XVS). The company has also announced the US launch of xvision spine, an AR guidance system to be used in surgery.
xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient 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.
The xvision system consists of a transparent near-eye-display headset and all elements of a traditional navigation system. It helps determine the position of surgical tools in real time and superimposes a virtual trajectory on a patient’s CT data. The 3D navigation data is then projected onto the surgeon’s retina using a headset, allowing them to simultaneously look at a patient and view navigational data without averting their eyes to look at a remote screen during a procedure. The system is designed to assist surgeons by giving them better control and visualization, which the company hopes will lead to easier, faster and safer surgeries.
Augmedics stated that it successfully completed a percutaneous (via needle-puncture of the skin) laboratory study with the xvision Spine at Rush University Medical Center, wherein ninety-three screws were positioned in the thoracic and sacro-lumbar areas of five different cadavers. The study was conducted as evidence to the FDA to evaluate the accuracy of the xvision Spine system by comparing the actual screw tip position and trajectory versus the virtual information. The result of overall clinical accuracy, analyzed by two independent neuro-radiologists, was 98.9 percent using the Heary (thoracic) and Gertzbein (lumbar) scales. The company also obtained further evidence of accuracy and usability last year in another cadaver study, which was conducted at Vista Labs in Baltimore, the results of which were published in the Journal of Neurosurgery: Spine.
“The ability that Augmedics’ xvision provides to visualize the patient’s spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing,” said Frank Phillips, M.D., Professor of Orthopaedic Surgery, Rush University Medical Center. “The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field – as well as the ability to ‘see the spine’ through the skin in minimally invasive procedures – differentiates the xvision from conventional spinal navigation platforms. The economics of the xvision system are also compelling in both the hospital and the surgicenter environment.”
Nissan Elimelech, founder and CEO of Augmedics, commented: “Augmedics’ mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow.” Elimelech added, “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.”
xvision is now available for sale in the United States, with headset distribution expected to begin in early 2020. Augmedics stated that it plans to explore additional surgical applications for xvision beyond spinal surgery. The company also noted that its system is designed to allow easy integration into any surgical facility nationwide, thanks to its small footprint, cost and compatibility with current instrumentation.
Video credit: Augmedics/YouTube