FDA Clears Pie Medical Imaging's Caas A-Valve System for Measuring Aortic Regurgitation Based on X-Ray Angiography

February 23, 2015—Pie Medical Imaging BV announced that it received 510(k) clearance from the US Food and Drug Administration for the company’s Caas A-Valve product, including the quantitative Regurgitation Analysis (qRA) workflow. The qRA workflow is an image analysis technology that is used to determine aortic regurgitation based on x-ray angiography.

According to the company, the qRA 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 qRA workflow quantifies regurgitation directly after percutaneous valve replacement. In addition to the qRA workflow, Caas A-Valve assists in defining the optimal C-arm projection to place the prosthetic valve, advised Pie Medical Imaging.

In the company’s press release, Prof Carl J. Schultz, MD, commented, “The qRA 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.” Prof. Schultz is with Royal Perth Hospital at The University of Western Australia in Perth, Australia.