– Augmedics announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first 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 accurately navigate instruments and implants while looking directly at the patient, rather than a remote screen.
Today, Augmedics announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery. The system is designed to revolutionize how the surgery is done by giving the surgeon better control and visualization, which may lead to easier, faster and safer surgeries.
Groundbreaking AR System Allows Surgeons to Visualize Anatomy in Real-Time
The xvision consists of a transparent near-eye-display headset and all elements of a traditional navigation system. It accurately determines the position of surgical tools, in real-time, and a virtual trajectory is then superimposed on the patient’s CT data. The 3D navigation data is then projected onto the surgeon’s retina using the headset, allowing him or her to simultaneously look at the patient and see the navigation data without averting his or her eyes to a remote screen during the procedure. The system is designed to revolutionize how the surgery is done by giving the surgeon better control and visualization, which may lead to easier, faster and safer surgeries. xvision is now available for sale in the United States, with headset distribution expected to begin in early 2020.
Successful Percutaneous Lab Study
Augmedics successfully completed a percutaneous laboratory study with the xvision Spine at Rush University Medical Center with investigators Frank Phillips, M.D., Camilo Molina, M.D., Kornelis Poelstra, M.D., Ph.D., Larry Khoo, M.D., and Matthew Colman, M.D. 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. The result of overall clinical accuracy, analyzed by two independent neuro-radiologists, was 98.9 percent using the Heary (thoracic) and Gertzbein (lumbar) scales.
This study adds to the evidence of accuracy and usability found last year in another cadaver study performed by two surgeons from Johns Hopkins Medicine, Daniel Sciubba, M.D., and Timothy Witham, M.D., one surgeon from Sheba Tel-Hashomer, Israel, Ran Harel, M.D., and one from Assaf Harofeh, Israel, Yigal Mirovsky. The study last year was conducted at Vista Labs, an independent lab in Baltimore, with results published in the Journal of Neurosurgery: Spine.
Impact of xvision
“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.”
