ANKYRAS
Mentice Spain S.L.ANKYRAS is a medical software device designed to assist clinicians in visualizing cerebral blood vessels and simulating the placement and sizing of neurointerventional braided endovascular devices such as flow diverters. It helps physicians plan neurovascular interventions by allowing 3D modeling based on imaging data from 3D rotational angiography, offering features like segmentation, centerline generation, and device simulation to improve pre-surgical planning and patient outcomes.
Intended Use
ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. It allows computational modeling of neurointerventional braided endovascular devices to assist physicians in planning interventions.
Technology
ANKYRAS uses 3D rotational angiography (3DRA) images or VTK surface models of target arteries to create vessel segmentations and centerlines. It simulates the placement of braided endovascular devices such as flow diverters by calculating length, expansion, and porosity, providing interactive visualization and measurements for preoperative planning. The software operates on standalone, WebGL, and mobile platforms compatible with Windows, Android, and iOS.
Performance
Software verification and validation testing showed successful import and processing of DICOM images, anatomic reconstruction visualization, report creation, and cybersecurity assessments. Computational modeling accuracy was validated against in vitro phantom studies and retrospective clinical image comparisons, showing ANKYRAS accurately estimates flow diverter placement metrics comparable to manufacturer specifications and imaging ground truth. All tests passed demonstrating the software meets performance requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/21/2025
3 months - 2
FDA Approval
5/6/2025
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