30 Day Trial

Augmedics' First-in-Human Trial of xvision-spine Underway


Augmedics commenced a first-in-human clinical trial of the xvision-spine (XVS) augmented-reality surgical navigation system at two centers in Israel.

The open label, prospective, single arm, multi-center study will evaluate XVS for pedicle screw placement during spinal fusion in eight to 22 subjects, depending on the number of screws placed in each subject, with a minimum of 85 total screws to be placed.

As we have written previously, XVS is designed to give surgeons “x-ray vision” during complex procedures, allowing them to see and navigate inside anatomy through skin and tissue. Spine is the first application that Augmedics is pursuing, with trauma and other orthopaedic segments to follow.

This first-in-human trial follows the company's successful second cadaver study, which completed in November 2017 and yielded 96.7% placement accuracy in the placement of 120 pedicle screws in five cadavers.

Sources: Augmedics; ORTHOWORLD Inc.