Monday, December 23, 2024

VisAR Augmented Reality Surgical Guidance System Using Low-Cost Off-the-Shelf HoloLens 2 Hardware Achieves Results in Spine Surgery

Novarad announced the publication of the article Augmented Reality Spine Surgery Navigation: Increasing Pedicle Screw Insertion Accuracy for Both Open and Minimally Invasive Spine Surgeries authored by surgeons participating from University of Utah, Georgetown University and University of Washington in the June 2022 issue of SPINE (volume 47, number 12). The article presents accuracy data for open and minimally invasive pedicle screw navigation achieved by its next generation augmented reality (AR) surgical guidance technology, VisAR.

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VisAR recently received 510(k) FDA clearance. The VisAR system translates the patient’s radiologic imaging data into a 3D hologram which is precisely superimposed on the patient by hologram-to-patient optical code alignment. The system is an off-the-shelf HoloLens 2 (Microsoft) AR visor, which uses transformative software developed by Novarad for precision guided open and minimally invasive spine surgery (MISS).

According to Dr. Wendell Gibby, CEO of Novarad, “The VisAR technology holds great promise for improving patient care by reducing operating room (OR) times, decreasing radiation to the patient and OR personnel, improving surgical accuracy and significantly democratizing access due to much lower cost than traditional navigation and robotic surgical approaches.”

Imaging data is retrieved via encrypted QR code, wirelessly uploaded to the headset, which then allow surgeons to follow a virtual pathway for precise navigation. Using workflow automation. OR setup time and registration occurs in less than 2 minutes. Out of 124 pedicle screws, ranging from T6 to L5, sixty-five of the screws were placed during open dissection with the remainder, fifty-nine, inserted percutaneously. The combined accuracy, open and MISS, was 96% (Gertzbein-Robbins scale). There was no statistical difference in the distributions of the two surgical methods. In addition, the mean angle of error was 2.4° (SD 1.2°) and the mean distance error was 1.9mm (SD 0.9mm). Fluoroscopy was not used during these procedures, minimizing exposure to radiation for the patient, surgeon, and OR staff. VisAR responds to voice commands for smooth operational control and to maintain OR sterility, with a nominal OR footprint.

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