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Indications, Safety, & Warnings

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 whom 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.

®*Third-party brands are trademarks of their respective owners.

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CathWorks is now part of Medtronic!

Alert Indications, Safety, and Warnings

We are excited to welcome the CathWorks FFRangio™ system to our portfolio.

This milestone represents the culmination of a four-year partnership. We are excited to welcome the CathWorks team and their expertise as we push the boundaries of coronary physiology.

Learn more about CathWorks

The new standard in coronary physiology1

Wire-free, drug-free, multivessel physiology

The system uses a wire-free, drug-free approach to convert routine angiograms into a map of the entire coronary tree, with FFRangio values at every point.
 

Optimized clinical decision-making1

The CathWorks FFRangio™ system equips physicians with deep insights to make critical, patient-focused decisions. Built-in tools support planning and optimizing the treatment of coronary artery disease (CAD).†,1

1. Pullback curve

The pullback curve differentiates functional patterns of CAD to target critical segments.
 

2. Lesion impact analysis

A lesion impact analysis enables the user to exclude a lesion and assess its clinical significance in cases with tandem lesions or mixed disease.
 

3. Sizing tool

The sizing tool accurately measures2 lesion dimensions and co-registers on the angiograms for an alternate view.

Unmatched outcomes1

The ALL-RISE trial data adds to the robust clinical evidence supporting the CathWorks FFRangio™ system1,3–5 and promotes the use of coronary physiology in assessing and treating CAD.

  • Demonstrating a one-year MACE‡ rate noninferior to wire-based physiology in the ALL‑RISE trial1
  • Providing statistically significant improvement in resource utilization and reduced procedure time1
See the ALL-RISE data

  

Stay connected.

Sign up for relevant updates and resources and stay informed as we continue to push coronary physiology forward.
 

Indicates Required Field

The information provided by the CathWorks FFRangio™ system is intended to be used by a qualified clinician in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation.

† Conditions for use and a full overview of the CathWorks FFRangio™ system can be found in the product user manual.

‡ MACE is a composite rate of all-cause death, myocardial infarction, and unplanned revascularization at one year.

1. Fearon WF, Jeremias A, Witberg G, et al. Angiography-derived fractional flow reserve to guide PCI. N Engl J Med. Published online March 29, 2026. doi:10.1056/NEJMoa2600949.

2. Dan K, Witberg G, Itabashi F, et al. Comparison of angiogram-based physiological assessment system sizing tool and intravascular ultrasound imaging measurements. Cardiovasc Revasc Med. 2025;78:80–85. doi:10.1016/j.carrev.2025.03.012.

3. Fearon WF, Achenbach S, Engstrom T, et al. Accuracy of fractional flow reserve derived from coronary angiography. Circulation. 2019;139(4):477–484. doi:10.1161/CIRCULATIONAHA.118.037350.

4. Witberg G. One-year clinical outcomes of FFRangio-guided treatment of coronary artery disease. Presented at: EuroPCR 2023; May 16–19, 2023; Paris, France.

5. Matsuo H. Prospective randomized trial evaluating clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve. Presented at: TCT 2024; October 27–30, 2024; Washington, D.C.

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Phone: 763-514-4000

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