Pie Medical Imaging BV has received 510(k) clearance from the US Food and Drug Administration for its CAAS A-Valve product including the quantitative regurgitation analysis workflow. The workflow is the first 510(k)-cleared image analysis technology to determine aortic regurgitation based on X-ray angiography.
The quantitative regurgitation workflow provides objective and reproducible quantification of aortic regurgitation by using density of contrast in the aortic root and ventricle based on X-ray aortogram images. Visual determination is inaccurate and can lead to underestimation of regurgitation. The quantitative regurgitation workflow is developed to quantify the regurgitation directly after percutaneous valve replacement. In addition to the quantitative regurgitation workflow, CAAS A-Valve assists to define the optimal C-arm projection to place the prosthetic valve.
“The quantitative regurgitation workflow is the first technology to enable an objective and reproducible method for grading aortic regurgitation on contrast aortography and can be used in clinical practice or research,” said C Schultz, Royal Perth Hospital, University of Western Australia.