Aortic Regurgitation Measurement Based on X-Ray Imaging Receives 510(k) Clearance

Maastricht, the Netherlands, February 23rd, 2015 — Pie Medical Imaging BV announced today that it received 510(k) clearance from the U.S. Food and Drug Administration for its CAAS A-Valve product including the quantitative Regurgitation Analysis (qRA) workflow. The qRA workflow is the first 510(k) cleared image analysis technology to determine aortic regurgitation based on X-ray angiography.

Quantification of Aortic Regurgitation measurement based on X-ray
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 is developed to quantify the regurgitation directly 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.”   said Professor, C. Schultz, MD, Royal Perth Hospital, The University of Western Australia.

About Pie Medical Imaging BV
Pie Medical Imaging BV has more than 30 years of experience in cardiovascular analysis software and is well known for its CAAS and 3mensio product lines. Pie Medical Imaging, develops and markets software for diagnosis and planning of treatment, guidance and quantitative analysis of cardiovascular images. The company is based in Maastricht and is part of the Esaote group. Esaote S.p.A. is worldwide provider of Ultrasound and dedicated MRI. More information is available at: www.piemedicalimaging.com.