FFRangio

by CathWorks  · Based in Israel → — A New Era in Coronary Physiology: Drug-free • Wire-free • Multi-vessel
Cardiology Radiology
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Regulatory Status Disclosed

Overview

The CathWorks FFRangio® System is an innovative angiography-derived physiology (ADP) platform that leverages artificial intelligence (AI) and advanced computational science to provide a comprehensive physiological assessment of coronary artery disease (CAD). It transforms routine angiograms into a detailed 3D model of the coronary tree, allowing physicians to obtain Fractional Flow Reserve (FFR) values at every point along the vessels.

This non-invasive system eliminates the need for traditional invasive pressure wires and drug stimulation (such as adenosine), thereby minimizing procedural risk, radiation exposure, and associated costs. FFRangio streamlines the procedural workflow in the cath lab with an intuitive user interface and seamless integration with existing equipment like the boom and PACS. It aids in quick angiogram analysis and offers advanced tools such as a simulated pullback curve to differentiate functional patterns of CAD, a Lesion Impact feature to assess residual ischemia, and an integrated sizing tool for non-invasive lesion measurements.

The FFRangio System is designed to empower interventional cardiologists with objective, real-time data to optimize Percutaneous Coronary Intervention (PCI) therapy decisions and improve patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI and advanced computational science for physiological assessment
  • Obtains FFR values from routine angiograms
  • Eliminates need for invasive pressure wires and drug stimulation
  • Provides quick, reliable intraprocedural FFRangio values for entire coronary tree
  • 3D reconstruction of the coronary tree
  • Simulated pullback curve to differentiate functional patterns of CAD
  • Lesion Impact tool for assessing residual ischemia
  • Integrated sizing tool for non-invasive lesion measurements
  • Intuitive user interface
  • Seamless integration with cath lab boom and PACS

Use Cases

  • Diagnosing coronary artery disease (CAD)
  • Optimizing Percutaneous Coronary Intervention (PCI) therapy decisions
  • Comprehensive physiological assessment of the coronary tree
  • PCI planning and guidance
  • Guiding coronary stent placement decisions
  • Reducing procedural risk and radiation exposure

What Physicians Need to Know

Coronary Artery Assessment
FFRangio uses artificial intelligence and advanced computational science to analyze routine angiograms (X-rays) and create a 3D model of the coronary tree. It provides Fractional Flow Reserve (FFR) values for the entire coronary tree, identifying the location and severity of blockages without the need for invasive pressure wires or drug stimulation. The system offers real-time FFRangio values, a simulated pullback curve to differentiate functional patterns of Coronary Artery Disease (CAD), and a lesion impact tool to assess residual ischemia. It also includes an integrated sizing tool for non-invasive lesion measurements to support PCI planning.
AHA/ACC Guideline Alignment
FFR is an important diagnostic tool supported by strong clinical evidence and society guidelines. The FFRangio system aims to increase the utilization of physiological measurements in decision-making for stent placement, which has been underutilized due to the invasive nature of traditional FFR. The technology has received FDA approval in 2018 and Japanese regulatory approval in 2019, and its role in assessing coronary artery disease has been reinforced by a SCAI expert opinion.
Real-Time Alert Capability
The FFRangio system provides physicians with quick and reliable intraprocedural FFR values for the entire coronary tree. It offers real-time FFRangio values across the coronary tree, enabling streamlined assessment in multi-vessel disease and supporting optimized clinical decision-making during procedures.
Diagnostic Accuracy
FFRangio has demonstrated high diagnostic accuracy compared to wire-based FFR. Studies have shown a diagnostic accuracy of 93%, with sensitivity of 91% and specificity of 94%. The FAST-FFR pivotal study, which led to FDA approval, showed that angiography-derived FFR was highly accurate when compared with pressure-wire FFR. In a pooled analysis of five prospective studies, FFRangio demonstrated an excellent diagnostic accuracy of 93%.
Physician Tip

FFRangio offers a wire-free and drug-free approach to assess coronary artery disease, making physiological assessment practical for every patient. It integrates seamlessly into the cath lab workflow, with AI aiding in quick angiogram analysis and minimizing manual edits. The system provides comprehensive multi-vessel FFR values, a simulated pullback curve to differentiate functional disease patterns, and a lesion impact tool for evaluating the significance of lesions, which can aid in PCI planning. Physicians should be aware that the system's results are intended to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as their professional evaluation. While highly accurate, FFRangio results may be affected by marginal quality imaging data. The technology has been shown to reduce procedure time and resource utilization compared to traditional wire-based FFR. It's important to note that the Lesion Impact feature may not be available in all geographies or for all case types (e.g., Diagonal and Ramus cases).

The FFRangio System is designed for seamless integration into the cath lab, streamlining procedural workflow. It integrates with existing cath lab imaging systems, utilizing routine angiograms (X-rays) in DICOM format. The system allows for seamless integration with the boom and PACS (Picture Archiving and Communication System). Artificial intelligence aids in angiogram analysis, and the system can perform functional assessments on one side of the heart while acquiring images of the other side. Medtronic has also invested in CathWorks and is involved in promoting the FFRangio system.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentThe FFRangio System is a software device that uses routine angiograms (X-rays) to create a 3D model of the coronary tree and calculate FFR values. It integrates seamlessly with the cath lab's boom and PACS.
Mobile AppYes, CathWorks has a mobile app available on Google Play. The app allows users to scan, save, and share anonymized FFRangio reports, screenshots, or password-protected log files.
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Radiology

Support & Reliability

Training ProvidedUnknown

What the Web Says

FFRangio, developed by CathWorks, is an angiography-derived physiology (ADP) system that utilizes artificial intelligence and advanced computational science to assess coronary artery disease (CAD) from routine angiograms. Physicians and clinical studies generally view FFRangio positively, highlighting its diagnostic accuracy and potential to streamline workflow in the cath lab. It aims to provide comprehensive physiological assessment without the need for invasive pressure wires or hyperemic agents, which are typically used in traditional Fractional Flow Reserve (FFR) measurements. The system has undergone several iterations, with continuous improvements in efficiency and user-friendliness.

Overall: Positive

Strengths

  • High diagnostic accuracy, comparable to invasive wire-based FFR.
  • Wire-free and drug-free approach, eliminating the need for pressure wires, anticoagulation, and hyperemic agents (like Adenosine).
  • Streamlines procedural workflow, reducing procedure time and increasing efficiency in the cath lab.
  • Provides comprehensive multi-vessel FFR values across the entire coronary tree, including side branches, and offers PCI planning tools.
  • Reduces radiation exposure and contrast use compared to traditional methods.
  • Improved patient comfort and safety due to its non-invasive nature.

Limitations

  • Diagnostic performance compared to FFR wires has not been established for lesions immediately after PCI.
  • Accuracy may be adversely affected by marginal quality of imaging data (poor resolution, inaccurate lesion demonstration).
  • Questions about the accuracy of ADP for complex anatomy (left main, bifurcations, grafts) are still under investigation.
  • Requires three angiographic views for accurate analysis.

Based on reviews from: youtube.com, cath.works, hmpgloballearningnetwork.com, medtronic.com, prnewswire.com, dicardiology.com, vir.com.vn, cardiacwire.com, nih.gov, newswire.ca, cardiovascularbusiness.com, lelezard.com

Last updated: 2026-10-29

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Press & Coverage

cath.works
Landmark ALL-RISE® Trial Results Presented at ACC.26: CathWorks FFRangio Demonstrates Similar Clinical Outcomes to Invasive Wire-based Physiology Assessment
The ALL-RISE trial results, presented at ACC.26 and simultaneously published in the New England Journal of Medicine, showed that CathWorks FFRangio achieved non-inferiority to invasive pressure wire guidance for major adverse cardiac events at one year, with benefits in resource utilization and reduced procedure time.
2026-03
medtronic.com
Medtronic completes acquisition of CathWorks, expanding its leadership in transforming care for patients with cardiovascular disease
Medtronic has completed its acquisition of CathWorks, a medical device company focused on diagnosing and treating coronary artery disease. This acquisition follows a 2022 strategic partnership and co-promotion agreement for the CathWorks FFRangio® System.
2026-04
cath.works
Late-Breaking Clinical Trial Presentation of the First-Ever US Cohort of Over 4,000 CathWorks FFRangio Patients Demonstrates Similar Clinical Outcomes to Invasive Pressure Wire-Guided PCI through 2 Years
Presented at the CRT annual conference, this study highlighted the growing adoption of CathWorks FFRangio in the US and demonstrated similar clinical outcomes to invasive pressure wire-guided PCI over two years, based on US Medicare outcomes data.
2026-03
medtronic.com
Medtronic advances its innovation strategy with intent to acquire CathWorks
Medtronic announced its intent to acquire CathWorks, following a successful co-promotion agreement for the CathWorks FFRangio® System. The acquisition, valued at up to $585 million, aims to bolster Medtronic's interventional cardiology portfolio.
2026-02
wdayradionow.com
Essentia Fargo introduces new technology to assess coronary artery blockages
Essentia Health-Fargo is the first hospital in the Dakotas to utilize the CathWorks FFRangio System, which uses AI and computational science to evaluate coronary artery disease during cardiac catheterization procedures. The system provides quick results, may reduce radiation exposure, and eliminates the need for drug stimulation and invasive pressure wires.
2026-10
citeline.com
Medtronic Adds FFRangio To Cardiovascular Arsenal In $585M CathWorks Acquisition
Medtronic's $585 million acquisition of CathWorks aims to integrate the FFRangio angiography-derived physiology platform into its interventional cardiology portfolio, leveraging AI-derived physiology to make coronary physiology a standard part of cath lab cases without wires or drugs.
2026-04
cath.works
CathWorks Named a Finalist for “Best Technology Company Leadership Team” at 2025 Octane High Tech Awards
CathWorks was recognized as a finalist for the “Best Technology Company Leadership Team” at the 2025 Octane High Tech Awards.
2025-09
cath.works
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
The PROVISION Study, presented at EuroPCR 2025, showed that FFRangio guidance resulted in similar major adverse cardiac events (MACE) at one year compared to invasive FFR guidance, with potential economic and resource utilization advantages.
2025-05

Videos

Product demos, reviews, and walkthroughs for FFRangio.

View all on YouTube

Frequently Asked Questions

The CathWorks FFRangio System uses artificial intelligence and advanced computational science to analyze routine angiograms and create a 3D model of the coronary arteries. This system then evaluates the 3D model to identify blockages and calculate FFRangio values for the entire coronary tree, providing a comprehensive physiological assessment without the need for invasive pressure wires or drug stimulation. Its primary use is to help physicians determine the severity of coronary artery disease and guide treatment decisions, including whether a coronary stent is needed.
The CathWorks FFRangio System has received United States 510(k) clearance, Israel Amar approval, and Japan PMDA approval. It also fulfills the requirements for CE marking (0344) and is ISO 13485 & 27001 certified, indicating compliance with international standards for medical devices and information security.
Alternatives to CathWorks FFRangio include traditional wire-based Fractional Flow Reserve (FFR), which is considered the gold standard but is invasive and requires drug stimulation. Other emerging non-invasive or less invasive methods include Quantitative Flow Ratio (QFR), instantaneous wave-free ratio (iFR), FFR-CT (FFR calculated from CT angiography), and other AI-derived FFR technologies.
The effectiveness of FFRangio has not been evaluated for certain patient populations, including those presenting with STEMI, prior STEMI on the same side being evaluated, previous coronary artery bypass graft (CABG) surgery, heart transplant, valve surgery, or prior TAVI/TAVR. It is also not evaluated for subjects with moderate to severe aortic stenosis, LVEF ≤ 45%, or arteries supplying akinetic or severe hypokinetic territories. The quantitative lumen diameter and QCA measurements are dependent on the quality of the angiography data provided.
FFRangio is currently reported using a Category III CPT add-on code, +0523T, in conjunction with an applicable coronary angiography procedure code. Payment for FFRangio is contractor-priced, meaning it is determined by individual Medicare Administrative Contractors (MACs), and commercial payers set their own rates. While it is listed as status N in the Hospital Outpatient Prospective Payment System (HOPPS), meaning the service is packaged and not separately paid, incremental reimbursement may be available through complexity adjustments in certain circumstances. The cost of the FFRangio analysis may be captured in procedure charges for cost reporting and UB-04 billing.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed FFRangio

Funded through the company that built this tool.

Geisinger Ventures
Corporate VC AI T3
Danville, United States
$1M-$5M
Geisinger Ventures is the strategic investment arm of Geisinger Health System, the integrated rural-focused health network headquartered in Danville, Pennsylvania. The fund…
Care Delivery / Tech-Enabled Services Digital Health
Medtronic Ventures
Corporate VC T3
Minneapolis, United States
$1M-$5M
Medtronic Ventures is the corporate venture arm of Medtronic, the global medical device company, investing in companies that align with Medtronic’s strategic…
Diagnostics Digital Health
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