Augmedics has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its xvision Spine system (XVS), an augmented reality (AR) guidance system to be used in spine surgery.
The xvision consists of a transparent near-eye display headset and all elements of a traditional navigation system. It determines the position of surgical tools, in real time, and a virtual trajectory is superimposed on the patient’s CT data. The 3D navigation data is then projected onto the surgeon’s retina using the headset, allowing them to simultaneously look at the patient data and see the navigation data without averting their eyes to a remote screen during the procedure. In a press release, Augmedics said that the system is designed to revolutionise how surgery is done by giving the surgeon better control and visualisation.
Augmedics completed a percutaneous laboratory study with the xvision Spine at Rush University Medical Center (Chicago, USA) with investigators Frank Phillips, Camilo Molina, Kornelis Poelstra, Larry Khoo, and Matthew Colman. Ninety-three screws were positioned in the thoracic and sacro-lumbar areas of five 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 compared to the virtual. The result of overall clinical accuracy, analysed by two independent neuro-radiologists, was 98.9% using the Heary (thoracic) and Gertzbein (lumbar) scales.
“The ability that Augmedics’ xvision provides to visualise the patient’s spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing,” said Frank Phillips (Rush University Medical Center; Chicago; USA). “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.”
“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 of Augmedics. “xvision is our first product of many to follow that will revolutionise 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 US, with headset distribution expected to begin in early 2020.