Indications, safety, and warnings CathWorks FFRangio®* System

Indications for use

The CathWorks FFRangio®* System is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary artery physiology. The results of CathWorks FFRangio 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 evaluation.

Contraindications

There are no known contraindications for use of FFRangio.

Precautions

The safety and effectiveness of the FFRangio has not been established in pediatric patients.

FFRangio results may be adversely affected by the following:

• Marginal quality of the submitted imaging data (poor resolution, inaccurate lesion demonstration, etc.)

Quantitative lumen diameter and QCA measurements are representative of the geometric model and the accuracy is dependent on the quality of the angiography data provided.

Due to the possible variability in the FFRangio results, the results should be viewed as one of several clinical data points in addition to the patient’s angiographic images, clinical history, symptoms, other diagnostic tests, and an appropriately trained clinician’s clinical judgment to evaluate the patient.

Limitations

The effectiveness of FFRangio has not been evaluated for the following populations:

• Subjects presenting with STEMI or subjects who have had a prior STEMI on the same side that is being evaluated (right/left).
• Subjects who have had prior coronary artery bypass graft (CABG) surgery, heart transplant or valve surgery, or prior TAVI/TAVR.
• Subjects with presence of moderate to severe aortic stenosis.
• Subjects with LVEF ≤ 45%.
• Subjects with arteries supplying akinetic or severe hypokinetic territories.
• Coronary vessels with severe diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the vessel of interest.
• Coronary vessels associated with Left Main stenosis > 50%.
• Coronary vessels which are ectatic or involve an aneurism.
• Subjects with anatomy including a separate ostium in the left system.
• Subjects who have undergone PCI with stent to the target vessel in past 12 months, or the target vessel involves in-stent restenosis (including edges).

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

See the device manual for complete information regarding the instructions for use, indications, contraindications, limitations, warnings, precautions, potential complications/adverse events and use instructions. For further information, please call CathWorks at +1.888.889.CATH (2284) and/or consult the CathWorks website at cath.works.