Follow the progress of Hemolens Diagnostics
This website contains information intended only for persons professionally dealing with medical devices (e.g. for persons performing medical professions, for persons dealing with the distribution of medical devices). Please confirm that you are a medical device professional to proceed.
Follow the progress of Hemolens Diagnostics
August 19, 2022
The Hemolens research project aims to assess the diagnostic value of the Hemolens platform for comprehensive, non-invasive diagnostics of coronary artery disease, to improve patient prognosis. It includes a complete anatomical and functional assessment of blood flow in the coronary arteries.
The Hemolens study is carried out in two stages:
– stage 1: medical research experiment involving 65 people
– stage 2: clinical trial of the medical device involving 85 people.
Recruitment is scheduled for approximately 19 months. The prototype of the medical device tested in the study will provide diagnostic tools based on computer modelling with the use of computational fluid dynamics. The new Cardiolens FFR-CT Pro® Diagnostic Platform allows physicians to perform an independent functional assessment based on three-dimensional models of the patient’s coronary arteries, correlated with the visualization of the myocardium.
The use of this breakthrough proprietary technology may contribute to reducing the frequency of invasive diagnostic tests, and thus improving the patient’s comfort. Cardiolens FFR-CT Pro® diagnostics may enable earlier identification of patients requiring invasive treatment, which may consequently improve the prognosis in this group of patients.
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.