Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Brainlab Elements Trajectory Planning software (version 2.6) provides comprehensive image-based planning for neurosurgical procedures, utilizing anatomical image processing to define precise trajectories for stereotactic instrument placement. Its methodology incorporates specialized modules for stereotaxy and lead localization, supports various hardware systems like FHC STarFix, and has demonstrated its intended performance through rigorous verification, bench testing, and usability studies.

Brainlab Elements Trajectory Planning software, including its Stereotaxy, Lead Localization, and Cranial Planning components (version 2.6), is designed for image-based planning and review across pre-, intra-, and postoperative stages of neurosurgical and neurological procedures. Its primary function is to facilitate stereotactic surgery by enabling the precise placement of instruments and devices, such as catheters, depth electrodes for SEEG, leads for DBS, probes, and biopsy needles. The software processes and visualizes various anatomical images, including axial, coronal, and sagittal reconstructions, along with co-registrations, segmentations, and fiber tracts, to plan optimal surgical trajectories for these cranial procedures, supporting both frame-based and frame-alternative stereotaxy. The software's methodology involves creating trajectories (pathways for surgical instruments) and generating coordinates and measurements for surgical intervention, including stereotactic arc settings and FHC STarFix platform configurations. Different licensed roles—Trajectory, Stereotaxy, and Lead Localization—offer specific features, such as automatic lead detection in postoperative images by the Lead Localization element. Version 2.6 introduces new GUI functionalities for windowing, enhanced measurement tools (point and angle), and expanded hardware support for the Inomed SUSy Arc and FHC STarFix Stereotactic Platform, including FHC WayPoint anchor detection on CT scans. Performance was validated through software verification, bench testing demonstrating non-inferior anchor detection accuracy, and summative usability evaluations covering new workflows like STarFix platform planning, plan locking, and image overlay.

AI Regulatory Concerns

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• Q1. How does the automatic lead detection in the 'Lead Localization' element account for potential post-operative brain shift or edema?; What specific image co-registration algorithms are employed by the software, and what is their validated accuracy for different imaging modalities?; Are there any specific contraindications or patient populations for whom the use of FHC STarFix platform planning with this software is not recommended?; How does the software handle anatomical variations or pathological distortions when planning trajectories for depth electrode placement in SEEG procedures?; What are the quantifiable benefits in terms of accuracy, planning time, or surgical outcomes observed with Trajectory Planning 2.6 compared to version 2.5 or manual planning methods?