Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
Brainlab AGThe Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.
Intended Use
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures including biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and placement of anchor bolts for laser interstitial thermal therapy (LITT).
Technology
The system combines hardware and software, including an IGS platform with computer, touch display, infrared tracking camera, and uses optical tracking to continuously update the location of surgical instruments relative to patient anatomy on imaging. It supports active (robotic) and passive positioning devices for trajectory alignment, and includes indication-specific instruments for biopsy, SEEG, and LITT. Registration uses AI/ML-based landmark surface matching.
Performance
Performance testing included software verification and validation, usability evaluation during LITT workflow, and system accuracy testing under worst case clinical scenarios showing mean positional error ≤2 mm and angular error ≤2°, comparable to predicate devices. Electrical safety, EMC, biocompatibility, and mechanical testing were also performed. No clinical testing was needed due to established technology.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
2 months - 2
FDA Approval
1/28/2025
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