EndoNaut

The EndoNaut system provides intraoperative image guidance for endovascular procedures by overlaying preoperative 3D anatomical models onto live 2D fluoroscopy, assisting in precise device placement. Its methodology relies on advanced 2D-3D and 2D-2D image registration algorithms, supported by dedicated software and workstation hardware, designed to enhance visualization and navigation for a range of vascular interventions.

The EndoNaut system is an advanced imaging solution designed for intraoperative navigation and guidance during endovascular procedures, specifically targeting aorto-iliac and peripheral interventions. Its core methodology involves the fusion of preoperative 3D scan data (typically CT scans) with live 2D intraoperative fluoroscopic imagery. This overlay provides real-time localization assistance to clinicians, aiding in the precise positioning of guidewires, catheters, and other vascular devices. The system comprises the EndoNaut Software, which performs the image fusion and registration, and an associated EndoNaut Workstation. It is interoperable with the EndoSize software, which facilitates preoperative case planning, vascular structure visualization, and endoprosthesis selection, although alternatives for pre-op planning can be used. The system is indicated for treating patients with various endovascular diseases requiring procedures such as aortic aneurysm repair (AAA/TAA), angioplasty, stenting, and embolization within the thorax, abdomen, pelvis, and lower limbs. Scientifically, EndoNaut leverages image registration algorithms for its 2D-3D fusion (AI module) and 2D-2D fusion (PAD module for lower limbs, including panorama creation). The system features semi-automatic registration with automatic motion detection and options for manual adjustments and validation, an improvement over its predecessor. It supports data import/export with PACS and offers various visualization and measurement tools, such as drawing markers and tracking points. Performance and safety were evaluated through comprehensive testing, including unit, integration, interoperability (with EndoSize), performance, safety, and simulated use testing, all under a quality assurance system. The EndoNaut Workstation underwent electrical safety, EMC, functional, and mechanical testing, demonstrating compliance with relevant standards like ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 62366 (usability), and the IEC 60601 series for medical electrical equipment. These evaluations confirmed that the device performs as intended and meets its design specifications.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the accuracy of the semi-automatic 3D-2D registration in the AI module compare across different anatomical regions (thorax, abdomen, pelvis, lower limbs) and varying image quality of preoperative CT scans?; What is the typical learning curve for clinicians to become proficient in using the EndoNaut system, particularly the image fusion and dynamic update features during complex endovascular cases?; Are there specific patient anatomical variations or procedural complexities where the EndoNaut system offers a more significant advantage in terms of procedural time, radiation exposure, or contrast media usage compared to conventional fluoroscopic guidance?; How does the system handle potential discrepancies or deformations between the preoperative 3D model and the patient's actual anatomy during the procedure (e.g., due to patient positioning, respiratory motion, or device manipulation)?; What are the quantitative benefits observed in simulated use testing or clinical evaluations regarding the precision of guidewire and catheter placement when using EndoNaut compared to standard techniques?