Follow the progress of Hemolens Diagnostics
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Follow the progress of Hemolens Diagnostics
February 24, 2023
The research project ‘HEMOFLOW cloud platform for non-invasive hemodynamic diagnostics’, No. POIR.01.01.01-00-0393/19, aims to assess the diagnostic value of a cloud platform intended for comprehensive, non-invasive anatomico-functional diagnostics of coronary artery disease to improve prognosis.
The HEMOFLOW project is implemented in two phases:
HEMOFLOW is a prospective, multicentre investigation being conducted at reference cardiology research centers in Poland.
The planned number of patients to be enrolled in the study is 150, including 65 participants in the medical research experiment and 85 participants in the clinical investigation. Recruitment is planned to take approximately 19 months.
Enrollees are adult patients with a positive history of Chronic Coronary Syndrome (CCS) who have signed an informed consent to participate in the study and meet all of the following criteria:
The diagnostic technology tested in the study is based on computer modeling with Computational Fluid Dynamics (CFD). The diagnostic system will be available as a cloud-based service, operating on the Software as a Service model. The new diagnostic platform will enable physicians to perform a stand-alone structural and functional assessment based on a virtual three-dimensional reconstruction of the patient’s coronary arteries (virtual measurement of fractional coronary flow reserve – FFR) correlated with a three-dimensional visualization of the myocardium (virtual three-dimensional perfusion maps).
Once its efficacy has been confirmed in clinical trials, this solution will be a globally unique tool for the diagnostics of ischaemic heart disease.
The use of new solutions that combine the non-invasive anatomical evaluation of the coronary arteries with a functional CT-based assessment of any existing stenoses and resulting myocardial perfusion abnormalities will significantly increase diagnostic accuracy and enable earlier identification of patients requiring invasive treatment. In addition, it provides an opportunity to increase the proportion of invasive coronary interventions (PCI) performed within arteries with adequately documented myocardial ischemia, which will consequently improve 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.