FASTII international multicenter trial confirms high diagnostic accuracy of Pie Medical Imaging CAAS vFFR solution

MAASTRICHT, Netherlands, May 19, 2021 /PRNewswire/ -- Pie Medical Imaging ("PMI"), a global leader in cardiac imaging, today announced the conclusion of the FASTII trial and presentation of the results as a late breaking clinical trial at EuroPCR 2021.

CAAS vFFR is an innovative technology allowing the non-invasive physiological assessment of coronary lesions. It calculates a pressure drop and vFFR value using angiography images only, without the need for invasive coronary artery instrumentation and/or adenosine.

In the FAST II trial, under the leadership of principal investigators Joost Daemen, MD, PhD and Kaneshka Masdjedi (MD) 334 patients were included in 6 centers over 3 continents: Erasmus Medical Center (NL), CHU Lille (FR), Herzzentrum Dresden (DE), Centro Cardiologico Monzino (IT), Tokyo University Medical Center (JP) and Columbia University Medical Center (USA).

"In the FAST II trial," said Joost Daemen MD, PhD, principal investigator "We confirmed that vFFR as calculated using CAAS vFFR has a high diagnostic accuracy to detect FFR ≤ 0.80 in an international multi-center setting. vFFR is an accurate, fast and easy to use tool to assess coronary physiology."

The results of FAST II confirm the findings in the earlier FAST I and FAST Extend studies showing high diagnostic accuracy to estimate lesion significance and paving the way towards a broader adoption of physiological lesion assessment in routine practice.

"By these publications and studies, PMI is committed to continue developing innovate solutions to allow better and more efficient patient care. We want to thank all the participating sites and authors for their outstanding work and are proud of such cooperation," said René Guillaume, PMI Managing Director.

About Pie Medical Imaging

Pie Medical Imaging BV is a world leader in analysis and visualization of cardiovascular images in Maastricht (The Netherlands), it hosts the global sales for the CAAS and 3mensio product lines. PMI and 3mensio Medical Imaging are part of the Esaote Group, leader in the biomedical equipment sector, in particular the areas of ultrasound, dedicated MRI and Medical IT.  More information about PMI is available at www.piemedicalimaging.com

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