EndoNaut
Therenva SASEndoNaut is a medical imaging software system that helps doctors during endovascular procedures by overlaying three-dimensional vessel images from preoperative scans onto real-time two-dimensional fluoroscopy images. This assists clinicians in accurately positioning catheters, guidewires, and stents within blood vessels in areas like the thorax, abdomen, pelvis, and lower limbs, improving procedural outcomes and patient care.
Intended Use
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis, and lower limbs, assisting with treatments such as aortic aneurysm repair, angioplasty, stenting, and embolization.
Technology
EndoNaut provides intraoperative guidance for endovascular procedures by combining 3D preoperative CT scans and 2D fluoroscopic imaging via semi-automatic registration and image fusion. It runs on a dedicated workstation and interoperates with EndoSize software used for preoperative planning and sizing.
Performance
Verification and validation activities were conducted including risk assessment, usability reviews, design reviews, clinical evaluation, performance testing, safety testing, and simulated use testing. Testing of the new workstation model confirmed compliance with design specifications and relevant standards (ISO 14971, IEC 62304, IEC 62366, IEC 60601 series).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/2/2021
29 days - 2
FDA Approval
8/31/2021
Other devices from Therenva SAS
- EndoNaut2022 • 510K
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