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Hemolens Diagnostics B.V.
Konijnenberg 63 I Breda 4825 BC I
The Netherlands
Arjan.Groenevelt@hemolens.eu
+31 6 20 07 67 77
Hemolens Diagnostics Sp. z o.o.
Legnicka 48G
54-202 Wroclaw
Poland
VAT Id. NL863101537B01
National Business Registry: 84113790
VAT Id. PL5213714387
National Business Registry 363139231
Intended Use:
Cardiolens FFR-CT Pro is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Coronary Computed Tomography Angiography (CCTA) and optionally with Continuous Non-invasive Blood Pressure (CNBP) data for assessment of patients with suspected Chronic Coronary Syndromes (CCS). It provides hemodynamic diagnostic factor FFR-CT (Fractional Flow Reserve with Computed Tomography), a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images and optionally from CNBP measurement. The factor FFR-CT at the output of Cardiolens FFR-CT Pro device is intended to support the functional evaluation of coronary artery disease. The Cardiolens FFR-CT Pro outputs are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of Cardiolens FFR-CT Pro are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
