U.S. FDA clears CAAS A-Valve for aortic regurgitation measurement

PIE Medical Imaging BV’s CAAS A-Valve product has secured 510(k) clearance from the U.S. Food and Drug Administration, making the quantitative Regurgitation Analysis (qRA) workflow the first 510(k) cleared image analysis technology to determine aortic regurgitation based on X-ray angiography. 

 

The qRA workflow uses density of contrast in the aortic root and ventricle based on X-ray aortogram images to provide an objective and reproducible quantification of aortic regurgitation as opposed to visual determination, which is inaccurate and can lead to underestimation of regurgitation. It was developed for direct quantification of the regurgitation after percutaneous valve replacement. 

 

In addition to the qRA workflow, CAAS A-Valve assists to define the optimal C-arm projection to place the prosthetic valve.  

 

“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,” according to Professor C. Schultz, MD, Royal Perth Hospital, The University of Western Australia.

 

Maastricht, Netherlands-based Pie Medical Imaging BV is part of Esaote S.p.A., a worldwide provider of ultrasound and dedicated MRI. Backed by more than 30 years of experience in cardiovascular analysis software, Pie Medical Imaging BV is well known for its CAAS and 3mensio product lines. The company develops and markets software for diagnosis and planning of treatment, guidance, and quantitative analysis of cardiovascular images.