HeartFlow Analysis Intended Use

Indications for Use

The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFRCT, 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. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease.

The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The HeartFlow Analysis is 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. It is for prescription use only.

HeartFlow Planner is a non-invasive, interactive pre-procedure scenario planning feature that uses an idealized coronary anatomy model and physiology simulation from the HeartFlow Analysis to assess FFRCT changes as a result of anatomic modification to the coronary lumen boundary. The idealized coronary anatomy model is derived from the CCTA anatomy and simulates a patient model free of stenosis. The Planner enables physicians to remove one or more (if multiples exist) modeled stenosis to virtually explore various treatment plans for a patient.