Indications for Use

HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides 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. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT 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. It is for prescription use only.

Limitations

The safety and effectiveness of the HeartFlow Analysis has not been evaluated for the following populations:

  1. Suspicion of acute coronary syndrome (where acute myocardial infarction or unstable angina have not been ruled out)
  2. Recent prior myocardial infarction within 30 days
  3. Complex congenital heart disease
  4. Prior coronary artery bypass graft (CABG) surgery
  5. Patients with a Body Mass Index >35
  6. Patients who require emergent procedures or have any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure

Due to the potential for artifacts in the CT data or degradation of CT data quality, the safety and effectiveness of the HeartFlow Analysis has not been evaluated for the following populations:

  1. Patients with prior pacemaker or internal defibrillator lead implantation
  2. Patients with prosthetic heart valves
  3. Patients with significant arrhythmias or tachycardia (uncontrolled by medication) that would preclude CT acquisition
  4. Coronary vessels with excessive calcification