Augmedics to roll-out xvision following FDA approval 1

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Chicago-based Augmedics has received regulatory approval from the US Food and Drug Administration (FDA) for its augmented reality (AR) image guidance system for spinal surgery.

Quick read

➨ Xvision is now available for sale in the US, with headset distribution expected to begin in early 2020

➨ The system allows surgeons to visualise the 3D spinal anatomy of a patient during surgery

➨ A study found overall clinical accuracy of 98.9% using the Heary (thoracic) and Gertzbein (lumbar) scales

The story

Following receipt of 510(k) clearance from the FDA, xvision is now available for sale in the US, with headset distribution expected to begin in early 2020. Augmedics plans to explore additional surgical applications for xvision beyond spinal surgery.

Xvision Spine allows surgeons to visualise the 3D spinal anatomy of a patient during surgery and to accurately navigate instruments and implants while looking directly at the patient, rather than a remote screen.

The system consists of a transparent near-eye-display headset and other traditional navigational elements. It 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 them to simultaneously look at the patient and see the navigation data without averting their eyes to a remote screen during the procedure.

Augmedics successfully completed a percutaneous laboratory study with xvision Spine at Rush University Medical Center. 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, analysed by two independent neuro-radiologists, was 98.9% using the Heary (thoracic) and Gertzbein (lumbar) scales.

Augmedics to roll-out xvision following FDA approval
Xvision Spine allows surgeons to visualise the 3D spinal anatomy of a patient during surgery and to accurately navigate instruments and implants while looking directly at the patient

Frank Phillips, professor of orthopaedic surgery at Rush University Medical Center, said: “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.”

“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’s mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow. 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.”

Image credits: Augmedics