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

See What’s New for vascuCAP® in 2018

510(k) Clearance Summary

Clinical Edition Release Brochure (US)

Indications for Use