Augmedics began its first-in-human clinical trial for the xvision-spine augmented-realty surgical navigation system.
Here are six highlights:
1. The clinical trial is taking place at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, both in Israel, and led by Dr. Ran Harel and Yigal Mirovsky.
2. The open label, prospective, single arm, multi-center study evaluates the safety, performance, accuracy and usability of the system during spine fusion procedures that require pedicle screw placement.
3. Between eight and 22 patients will be included in the study with a minimum of 85 total screws placed. The first case was completed Aug 5. The remaining cases will continue for the following three months.
4. Augmedics brought in two independent radiologists to test the system's pedicle screw placement accuracy. This human trial follows Augmedics' second cadaver study.
5. XVS is designed to give surgeons increased visibility during complex procedures. Surgeons can see and navigate inside a patient's body through skin and tissue. Additionally, the system comprises a transparent near-eye-display headset and the elements of traditional navigation systems.
6. Augmedics designed the system to project a 3D image of the patient's spine on a surgeon's retina in real-time.