Device profile of the XVision-spine (XVS) augmented-reality surgical navigation system: overview of its safety and efficacy

ABSTRACT

Introduction: The field of augmented reality mediated spine surgery is growing rapidly and holds great promise for improving surgical capabilities and patient outcomes. Augmented reality can assist with complex or atypical cases involving challenging anatomy. As neuronavigation evolves, fundamental technical limitations remain in line-of-sight interruption and operator attention shift, which this novel augmented reality technology helps to address.

Areas covered: XVision is a recently FDA-approved head mounted display for intraoperative neuronavigation, compatible with all current conventional pedicle screw technology. The device is a wireless, customizable headset with an integrated surgical tracking system and transparent retinal display. This review discusses the available literature on the safety and efficacy of XVision, as well as the current state of augmented reality technology in spine surgery.

Expert opinion: Augmented-reality spine surgery is an emerging technology that may increase precision, efficiency, and safety as well as decrease radiation exposure of manual and robotic computer-navigated pedicle screw insertion techniques. The initial clinical experience with XVision has shown good outcomes and it has received positive operator feedback. Now that initial clinical safety and efficacy has been demonstrated, ongoing experience must be studied to empirically validate this technology and generate further innovation in this rapidly evolving field.

KEYWORDS:

• Augmented reality
• mixed reality
• computer assisted spine surgery
• spine navigation
• minimally invasive spine surgery

Article Highlights

• Augmented reality has applications in spine surgery for assisting operators with understanding complex 3D anatomy, and neuronavigation technologies are developing rapidly.

• XVS is an augmented-reality headset to assist spine surgeons with pedicle screw instrumentation, a key technique in many common spine procedures.

• The device consists of a wireless headset comprised an optical tracking camera, integrated graphics-processing unit (GPU), light source, and retinal displays. The device overlays navigational data directly on the operative field in an anatomically matching dimension and orientation.

• It is developed to address several current limitations in spine surgical neuronavigation, including tracking the camera line of sight obstruction and attention shift, common problems in the modern operating room.

• XVS was approved by the FDA as a class II device in December 2019 after cadaveric studies and has been used successfully in multiple cases and institutions. The clinical experience is early and published data is only available from a single institution thus far.

• Importantly, it is vendor and implant neutral, and can be used to decrease the cost of spine surgery.

• The field of spine surgical neuronavigation continues to advance and devices like XVS will play an important role in better outcomes for patients, decreased costs, and improved surgeon satisfaction.

Declaration of interest

CA Molina is a consultant for Augmedics Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One peer reviewer is a consultant for Brainlab. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.