First AR Spine Surgery Using Augmedics xvision Completed in U.S.

Augmedics’ xvision Spine System has been successfully used for the first time in a spinal fusion surgery in the United States. The system was used in a spinal surgery procedure by Johns Hopkins University surgeons.

xvision, an Augmented Reality Guidance system for surgery, 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. The xvision Spine System takes the best of surgical navigation systems and improves upon them to meet the needs of surgeons and provide technical confidence in the operating room.

The surgery with the xvision Spine System was a posterior lumbar decompression, slipped vertebrae (spondylolisthesis) correction, and fusion. It was performed on June 8 at The Johns Hopkins Hospital in Baltimore, Maryland, by Dr. Timothy Witham, director of the Johns Hopkins Neurosurgery Spinal Fusion Laboratory, along with Dr. Daniel Sciubba, director of Spine Tumor and Spine Deformity Surgery in the Department of Neurosurgery at Johns Hopkins and Dr. Camilo Molina, resident, Neurological Surgery at Johns Hopkins.

“Today marks a new era in spine surgery,” said Nissan Elimelech, founder and CEO, Augmedics. “This first case is just the beginning of a revolutionary change to the way surgery is performed by providing surgeons with more control, giving them the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow, and to help surgeons perform as safely and effectively as possible. We expect xvision will dramatically improve accuracy, safety, operating efficiencies and patient outcomes in an environment that increasingly can tolerate nothing less.”

‘An Unmet Clinical Need in Spine Surgery’
Each year there are approximately 1.62 million instrumented spinal procedures performed in the United States alone. The majority of those are done using a freehand technique, which can lead to suboptimal outcomes, including up to 31 percent of freehand surgeries result in inaccurate screw positioning; neurological complications due to screw malposition in 2.3 percent of cases; and, up to three percent require reoperation within 30 days to reposition screws, creating the possibility of more surgical-related complications.

Surgical navigation systems significantly improve the outcomes, with more than 95 percent success rate as a result of better accuracy. They also cut screw insertion time by 50 percent and provide a 92 percent decrease in X-ray radiation. However, only nine percent of spine surgeons routinely use them and 66 percent never do. This can be attributed to a number of factors: surgeons find them to be uncomfortable, and they do not meet surgeons’ expectations in terms of time efficiency, ease of use, and integration into the surgical workflow. In addition, they distract surgeons from their patients by requiring them to look at a remote screen across the room or placed at the patient’s feet.

To address the unmet needs of surgeons, the xvision Spine System 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. In a minimally invasive procedure, 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 surgery is done by giving the surgeon better control and visualization, which may lead to easier, faster and safer surgeries. In a percutaneous cadaver study, the xvision Spine System demonstrated 98.9 percent screw placement accuracy.

In December, Augmedics announced FDA 510(k) clearance and the U.S. launch of its xvision Spine system (XVS). xvision is now available for sale in the United States, with headset distribution underway. Augmedics plans to explore additional surgical applications for xvision beyond spinal surgery.