Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of its Xvision Spine augmented reality guidance system to be used in surgery.
The company is touting Xvision Spine as the first AR guidance system to be used in surgery. The system is designed to allow surgeons to visualize the 3D spinal anatomy of a patient during surgery as if it were “X-ray vision.” The vision allows the surgeon to accurately navigate instruments and implants while looking directly at the patient instead of a remote screen, Augmedics said in a news release.
The platform includes a transparent near-eye display headset and determines the position of surgical tools in real-time, while a virtual trajectory is superimposed on the patient’s CT data. The device projects 3D navigation data onto the surgeon’s retina, allowing him or her to simultaneously look at the patient and see navigation data without looking at a remote screen.
A study of the Xvision Spine system at Rush University Medical Center in Chicago positioned 93 screws in the thoracic and sacro-lumbar areas of five cadavers, comparing the actual screw tip position and trajectory to the virtual, according to Augmedics. Results revealed 98.9% accuracy using the Heary (thoracic) and Gertzbein (lumbar) scales. The company launched the first-in-human clinical trial of its Xvision Spine system in August 2018.
Xvision is now available for sale in the U.S., as Augmedics said it expects headset distribution to begin in early 2020.
“Augmedics’ mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow,” Augmedics founder & CEO Nissan Elimelech said in the release. “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.”
“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,” added Rush University Medical Center professor of orthopedic surgery Dr. Frank Phillips. “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.”