Clinical Edition, US

vascuCAP® Clinical Edition is an image analysis tool for evaluating routinely available CT images of arterial vessels ≥ 4.5mm in diameter now available for clinical use in the United States. vascuCAP® provides multi-dimensional visualization and measurements to aid clinicians in their analysis of arterial anatomy and tissue characteristics. With vascuCAP®, tissue characteristics implicated in high risk atherosclerotic plaque may be quantitatively measured from CT Angiography(CTA) in high correlation with histopathology.
Available anatomical visualization and measurement for clinical decision support include:

  • Lumen diameter and wall thickness, shape, and cross-sectional area at 0.5mm intervals along a calculated centerline of one or more chosen arterial segments or multi-segment paths.
  • Aggregates of cross sectional data including lumen-wall ratios (stenosis, dilation, plaque burden, and remodeling ratio) segmental and overall volumes by segment or path.
  • Length, cross sections and aggregate data of user-defined lesions or other regions of interest.
  • Measurement of calcified plaque, lipid-rich necrotic core, and matrix areas of interest for each vessel segment or path under user supervision;
    •  vascuCAP® is designed to mitigate overestimation of calcification on CTA;
    • vascuCAP® is designed to mitigate underestimation of lipid rich necrotic core on CTA;
  • Aggregation of calcified plaque, lipid-rich necrotic core, and matrix area and volume statistics for each vessel, segment, path or user designated lesion (absolute and fractional occupancy);
  • Display of calcified plaque, lipid-rich necrotic core, and matrix regions of interest in multiple 2D and 3D formats for clinician to visualize the relative positions of each sub-region to the lumen for treatment planning and outcomes assessment.

vascuCAP® workflow facilitates reporting of the clinician’s quantitative findings with supporting visualization and comparison with prior findings using the CAPgraph® informatics solution.

The measurements provided by vascuCAP® are not intended to provide a diagnosis or clinical recommendations. vascuCAP® is intended as a tool to complement standard of care.

vascuCAP Clinical Release is now available for sale in the United States (K163071)

Apple and Windows Versions Available

510(k) Clearance Summary

Clinical Edition Release Brochure (US)

Indications for Use