Brainlab Elements Trajectory Planning (2.6)
Overview
Brainlab AG is a privately held German medical technology company headquartered in Munich, Bavaria. Founded in 1989, Brainlab develops advanced software and hardware solutions for radiotherapy, radiosurgery, and various surgical fields including neurosurgery, ENT, craniomaxillofacial, spine surgery, and traumatic interventions. Their products are designed to digitize, automate, and optimize clinical workflows, focusing on image-guided surgery, precision radiation therapy, digital operating room integration technologies, and cloud-based data sharing. The Brainlab Elements platform, which includes Trajectory Planning, offers a suite of state-of-the-art applications with advanced algorithms to assist clinicians in surgical targeting, planning, and verification, aiming to improve patient outcomes and treatment consistency.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Advanced 2D and 3D visualization for surgical planning
- Flexible 3D lead and electrode modeling
- Intuitive measurement tools for precise planning
- Fast, automatic, and accurate co-registration between image modalities
- Elements Distortion Correction Cranial for MRI distortion correction
- Patient-specific anatomy segmentation (e.g., Basal Ganglia, Cranial)
- Fibertracking with both probabilistic and deterministic algorithms
- Secure server with Lock Mode for saving surgical plans
- Automatic lead detection for post-operative accuracy verification
- Integration with various surgical delivery platforms
Use Cases
- Deep Brain Stimulation (DBS) planning
- Stereoelectroencephalography (sEEG) planning
- Cranial biopsy planning
- Catheter placement procedures
- Depth electrode placement
- Cranial resection procedures (e.g., eloquent and non-eloquent tumors)
What Physicians Need to Know
Leverage Brainlab Elements u2013 Trajectory Planning for precise and controlled planning of stereotactic procedures such as DBS, sEEG, and biopsies. Utilize the advanced image fusion, patient-specific segmentation, and fibertracking capabilities to customize lead implant geometry and visualize surgical plans in 2D and 3D, ensuring critical white matter tracts are identified and avoided. The tool supports pre-, intra-, and postoperative review, including automatic lead detection for verifying accuracy.
Brainlab Elements u2013 Trajectory Planning seamlessly integrates with other Brainlab Elements applications (e.g., Image Fusion, Distortion Correction Cranial, Segmentation, Stereotaxy) and can be incorporated into various surgical delivery platforms. It supports the integration of intraoperatively acquired data from iMRI, iCT, and other imaging devices via Automatic Registration technology. The system is designed to bridge different clinical departments, facilitating scalable connections across neurosurgery, spine surgery, orthopedics, and radiation oncology workflows, and allows for merging external planning data like STL files.
Details
| Category | Neurology AI, Surgical AI |
| Pricing | Contact for pricing — Variable, contact vendor for quote |
| Deployment | On-premise (workstation) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, and Elements Trajectory Planning Cranial received FDA 510(k) clearance (K223552) on April 19, 2023. It is classified as a Class II Stereotaxic Instrument under 21 CFR 882.4560. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Neurosurgery, Radiology |
What the Web Says
Brainlab Elements u2013 Trajectory Planning (2.6) is a software designed for pre-, intra-, and postoperative image-based planning and review of neurosurgical and neurological procedures, particularly for instrument placement in stereotactic surgery. It aims to enhance precision and improve patient outcomes by planning minimally invasive pathways using anatomical images and corresponding planning data. The software is part of the broader Brainlab Elements suite, which offers advanced visualization and planning tools for various medical specialties.
Overall: PositiveStrengths
- Provides GPS-level precision for brain and spinal surgeries, aiding in avoiding damage to vital functions.
- Automates much of the planning work, potentially reducing planning time by up to 80% and democratizing access to advanced treatments.
- Offers advanced 2D and 3D visualization, flexible 3D lead and electrode modeling, and intuitive measurement tools for trajectory planning.
- Includes Fibertracking module to visualize neural pathways, allowing surgeons to plan surgeries to protect critical areas like speech and movement.
- Supports various stereotaxy use cases such as Deep Brain Stimulation (DBS), sEEG, and biopsies, integrating into the surgeon's preferred delivery platform.
- Features an algorithm that creates patient-specific arc trajectories, optimizing dose delivery and minimizing radiation to organs at risk in cranial radiosurgery.
Limitations
- Requires proper hardware and user expertise for effective operation and accurate interpretation of processed images.
- AI features are highly dependent on the quality of input images and user-defined parameters.
- The cost of Brainlab navigation systems can be high, ranging from $400,000 to $800,000+, depending on specific needs and integrations.
- While automated planning is a pro, one study noted that Knowledge-Based Planning (KBP) plans took significantly longer to plan compared to Multiple Brain Metastases (MBM) plans within Brainlab Elements.
- The software is not intended for direct diagnosis or creating physical replicas from image data for diagnostic purposes.
- Dependence on proper hardware and user expertise.
Based on reviews from: FDA Radiology AI Device - X-ray Interpreter, Brainlab, FDA.report, FDA, YouTube, PDF Catalogs | Technical Documentation, Imaging Technology News, Medical News Observer, accessdata.fda.gov, OHSU Digital Collections, data2bids v3.1, Frontiers, PMC
Last updated: 2026-07-18
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