OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Description
With the Ultreon 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms are also measured by the system to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). The physician may use the resting full-cycle ratio (RFR) or fractional flow reserve (FFR) parameter, along with the knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
Detailed example
Displays measurements of interest.
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Support coronary artery scans.
Controls / human review
ATO: Not reported; PIA: Not published