ZETA 1. is indicated for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites. The use of the ZETA Cranial Navigation System for ventriculostomy, brain biopsy and transcranial magnetic stimulation require separate compatible instruments and accessories. ©️ 2026 ZETA Surgical Inc. All rights reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to ZETA Surgical, its subsidiaries or affiliates. No use of any ZETA Surgical trademark, trade name, or trade dress in this site may be made without the prior written authorization of ZETA Surgical, except to identify the product or services of the company.
EVD (External Ventricular Drain) First-in-Human Trial
January 1, 2024
National Neuroscience Institute, Singapore
First-in-human precision. 100% ideal placement.
ZETA was evaluated in a first-in-human clinical trial at Singapore’s National Neuroscience Institute, guiding ventricular cannulation procedures with real-time, vision-based navigation and no rigid skull fixation. The study demonstrated 100% ideal catheter placement, 100% single-pass success, and no significant complications.
THE CHALLENGE
Ventricular cannulation is a high-stakes procedure where accuracy directly affects patient safety.
Freehand placement can lead to catheter misplacement, multiple passes, hemorrhage, infection, or revision procedures.
Traditional navigation can improve guidance, but often depends on complex workflows, rigid reference systems, and OR-based infrastructure that limit broader clinical use.
OUR APPROACH
ZETA enabled frameless, real-time, vision-based navigation during ventricular cannulation:
- No rigid skull fixation
- Automatic image-to-patient registration
- Real-time markerless tracking
- Portable, single-cart system
- Rapid navigation setup
In this first-in-human study, all procedures were performed in the OR, allowing the system’s accuracy, workflow integration, and safety profile to be evaluated under controlled clinical conditions.
CLINICAL RESULTS
In the first-in-human study:
- 100% ideal catheter placement (vs. 32% freehand)
- 0% adverse events (vs. 28% freehand)
- 100% single-pass success (vs. 81% freehand)
- 0% revision surgeries (vs. 19% freehand)