Non-invasive, personalized diagnostics of coronary artery disease
Cardiolens FFR-CT Pro® allows for a detailed anatomical and functional evaluation of coronary arteries.
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Cardiolens FFR-CT Pro® allows for a detailed anatomical and functional evaluation of coronary arteries.
The FFR-CT-based technology developed by Hemolens allows for a detailed anatomical and functional evaluation of coronary arteries using computational fluid dynamic principles.
Cardiolens FFR-CT Pro® analyzes data from two non-invasive diagnostic methods:
Possibility to use the method also in patients with contraindication to coronary angiography
Reduced hospitalizations and related costs
Fast and safe diagnostic method
Reduced risk and improved patient comfort
Non-invasive tool to obtain quantitative functional results of stenosis severity
Improved planning of invasive procedures based on functional FFR-CT data
Reduced number of unnecessary invasive catheterizations and coronary angiographies
A technology for healthcare providers to accurately diagnose patients with suspected ischemic heart disease.
Assessment of cerebral blood flow and brain perfusion as a significant diagnostic parameter in the diagnosis and treatment of stroke and brain aneurysms (in development).
Evaluation of hepatic, renal and cerebral blood flow and angiogenesis levels as a tool in planning optimal radio- and chemotherapy (in development).
Evaluation of pulmonary blood flow as an important diagnostic factor in the prevention and diagnostics of lung diseases (in development).
Assessment of blood flow in large vessels such as the aorta or femoral artery is an important prognostic of thrombotic lesions and a useful tool in planning the surgical treatment of embolisms (in development).
Quality Management System certificate of compliance with PN-EN ISO 13485:2016 standard and CE Certificate for Cardiolens FFR-CT Pro® in accordance with Directive 93/42/EEC concerning medical devices.
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.
