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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.

HeartFlow Analysis 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 <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV) or acute pulmonary edema

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

HeartFlow Planner Limitations

The HeartFlow Planner models for an idealized lumen and does not account for percutaneous coronary intervention techniques and all of the resulting anatomic or physiologic responses. FFRCT values resulting from the HeartFlow Planner changes may not simulate the effects of the following:

  • Atherosclerotic plaque characteristics or shift
  • Calcium characteristics
  • Bifurcation architecture
  • Myocardial bridges
  • Incomplete stent expansion
  • Treatment of coronary total occlusion
  • Stent overlap
  • Coronary dissection
  • Longitudinally or radially asymmetric stent expansion

The FFRCT values resulting from the use of HeartFlow Planner after opening the lumen have not been clinically validated