FFRangio

by CathWorks  · Based in Israel → — Optimize Clinical Decision Making with the CathWorks FFRangio® System.
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 utilizes AI and advanced computational science to derive Fractional Flow Reserve (FFR) values from routine 2D angiograms, providing a comprehensive physiological assessment of the entire coronary tree. It generates an accurate 3D volumetric model of the coronary arteries and calculates resistance to blood flow along each segment. The system offers real-time FFRangio values, a simulated pullback curve to differentiate functional patterns of CAD, and an integrated sizing tool for non-invasive lesion measurements. A 'Lesion Impact' tool is also available in selected geographies to assess residual ischemia.
Diagnostic Accuracy
FFRangio has demonstrated high diagnostic accuracy (92-93%) compared to wire-based FFR in multiple studies, including the FAST-FFR pivotal trial. It has also shown comparable one-year Major Adverse Cardiac Event (MACE) rates to invasive FFR in randomized controlled trials (PROVISION Trial) and real-world registries.
Elimination of Invasive Tools/Drugs
The system eliminates the need for invasive pressure wires and hyperemic agents (like Adenosine), reducing procedural complexity, patient discomfort, and potential risks such as complications from anticoagulation or drug-induced blood pressure drops.
Reduced Radiation Exposure
FFRangio can lead to approximately a 20% reduction in radiation exposure compared to traditional wire-based physiological assessment.
Real-Time Guidance
The system provides real-time FFRangio values during the procedure, enabling immediate physiological assessment and optimizing clinical decision-making for percutaneous coronary intervention (PCI).
AHA/ACC Guideline Alignment
While traditional FFR has a Class 1A indication in guidelines, FFRangio offers a validated, wire-free alternative with comparable diagnostic accuracy and clinical outcomes, addressing the underutilization of physiological assessment.
Physician Tip

Utilize FFRangio's comprehensive, real-time physiological assessment of the entire coronary tree to optimize PCI planning and decision-making, particularly in cases of multi-vessel disease or tandem lesions. Leverage the wire-free and drug-free nature of the system to assess patients who might be at higher risk for complications with traditional invasive FFR, such as those with tenuous blood pressure or coagulopathies. Integrate FFRangio into the cath lab workflow to streamline procedures, reduce radiation exposure, and potentially increase the adoption of physiological guidance. Ensure optimal 2D angiogram acquisition (three angiograms, 30u00b0 apart, good opacification, end-diastolic frame) as it is crucial for accurate 3D model reconstruction and FFRangio calculation.

The CathWorks FFRangio System is designed for seamless integration with existing cath lab infrastructure, including the cath lab boom and Picture Archiving and Communication System (PACS). It processes routine 2D angiograms from standard imaging systems. While FFRangio focuses on angiogram-derived FFR, it can complement other AI-powered diagnostic tools like CT-based FFR analysis, though it does not perform CT/MRI analysis itself.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor
DeploymentOn-premise system integrated with cath lab equipment
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The CathWorks FFRangio™ System received United States FDA 510(k) clearance (K182149) in December 2018, and a subsequent 510(k) for modifications (K192442) in December 2019. It was the first non-invasive device of its kind to receive FDA clearance for use during Percutaneous Coronary Intervention (PCI) assessment.
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

FFRangio is a non-invasive, angiography-based system that utilizes artificial intelligence and advanced computational science to provide fractional flow reserve (FFR) values for the entire coronary tree from routine angiograms. This eliminates the need for invasive pressure wires and drug stimulation, which are typically required for traditional wire-based FFR. Physicians highlight its role in optimizing clinical decision-making, streamlining workflow, and potentially expanding the use of physiological assessment in the cath lab.

Overall: Positive

Strengths

  • Wire-free and drug-free, eliminating risks and inconveniences associated with traditional FFR methods.
  • High diagnostic accuracy compared to wire-based FFR.
  • Provides comprehensive multi-vessel coronary physiology and PCI planning tools, including real-time FFRangio values and simulated pullback curves.
  • Intuitive user interface and AI aid in quick angiogram analysis and simplify the operator experience.
  • Demonstrated comparable one-year major adverse cardiac event (MACE) rates to invasive FFR in clinical trials and real-world studies.
  • Can be integrated seamlessly into the cath lab workflow, potentially saving time.

Limitations

  • Diagnostic performance has not been established for lesions immediately after PCI.
  • Some useful features may be limited to higher plans, making the subscription potentially expensive (general G2/Capterra feedback, not specific to FFRangio).
  • The platform can sometimes feel a little heavy for new users when handling many files and revisions (general G2/Capterra feedback, not specific to FFRangio).

Based on reviews from: Cathworks FFRangio, FFRangio in Clinical Practice - An Interview with Dr. Antreas Hindoyan - CathWorks, CathWorks FFRangio System Case Review u2013 Highlight from Dr. Rahul Sharma's CVIT Presentation, Role of CathWorks FFRangio for the Assessment of Coronary Artery Disease Now Reinforced by SCAI Expert Opinion, Videos - CathWorks, CathWorks FFRangio Goes Beyond Physiology - Cardiac Wire, Deliver High Diagnostic Accuracy and Promising Outcomes with the CathWorks FFRangiou00ae System - YouTube, Beyond Physiology: Dr. Fearon Discusses CathWorks FFRangio's Robust Clinical Evidence, CathWorks' FFRangio system exceeds pre-specified performance goals, CathWorks FFRangiou2122 System Clinical Review Featured in TCT 2018 Program - BioSpace, Introducing the Latest FFRangio System u2013 Video Highlight from Dr. Rahul Sharma's CVIT Webinar - CathWorks, CathWorks FFRangio: Coronary Physiology Redefined - TCT 2024 - YouTube, Realu2010World Outcomes of FFRangiou2010Guided Treatment for Coronary Artery Disease in Acute Versus Chronic Coronary Syndromes - American Heart Association Journals, CathWorks: Home, Medtronic completes acquisition of SPR, expanding patient access to minimally invasive, non-opioid treatment of chronic and acute pain - Stock Titan, Landmark ALL-RISEu00ae Trial Results Presented at ACC.26: CathWorks FFRangio Demonstrates Similar Clinical Outcomes to Invasive Wire-based Physiology Assessment - PR Newswire, How Does FFRangio Work? u2013 Insights from Dr. Rahul Sharma's CVIT 2021 Presentation, CathWorks FFRangio - Enhancing patient care - EuroPCR 2024 - YouTube, 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 - PR Newswire, Medtronic completes acquisition of SPR, expanding patient access to minimally invasive, non-opioid treatment of chronic and acute pain - Stock Titan, The (R)evolution of Image-based FFR u2013 Introducing the CathWorks FFRangio System, Role of CathWorks FFRangio for the Assessment of Coronary Artery Disease Now Reinforced by SCAI Expert Opinion - PR Newswire, Investors - CathWorks, CathWorks FFRangio: Proven Outcomes without Compromise or Complications (TCT 2025, San Francisco, CA), FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial, Frame.io Reviews 2026: Details, Pricing, & Features | G2

Last updated: 2026-07-17

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Press & Coverage

PR Newswire
Landmark ALL-RISEu00ae Trial Results Presented at ACC.26: CathWorks FFRangio Demonstrates Similar Clinical Outcomes to Invasive Wire-based Physiology Assessment
The ALL-RISE Trial demonstrated that CathWorks FFRangio had similar clinical outcomes to invasive pressure wire guidance for major adverse cardiac events (MACE) at one year, with improved resource utilization and reduced procedure time. The results were simultaneously published in the New England Journal of Medicine.
2026-03
Medtronic
Medtronic completes acquisition of CathWorks, expanding its leadership in transforming care for patients with cardiovascular disease
Medtronic announced the completion of its acquisition of CathWorks, a medical device company focused on diagnosing and treating coronary artery disease, following a 2022 strategic partnership. The acquisition is valued at $585 million with potential undisclosed earn-out payments.
2026-04
American Heart Association Journals
Realu2010World Outcomes of FFRangiou2010Guided Treatment for Coronary Artery Disease in Acute Versus Chronic Coronary Syndromes
This study examined the real-world clinical outcomes of FFRangio-guided treatment for coronary artery disease in patients with acute versus chronic coronary syndromes, finding comparable two-year outcomes to wire-based fractional flow reserve. FFRangio is approved for use in the US, Japan, and Israel.
2026-05
CathWorks
Role of CathWorks FFRangio for the Assessment of Coronary Artery Disease Now Reinforced by SCAI Expert Opinion
The Society for Cardiovascular Angiography & Interventions (SCAI) published an expert opinion reinforcing the expanding role of angiography-derived physiology (ADP) like CathWorks FFRangio for coronary physiologic assessment. The opinion highlights FFRangio's comprehensive multi-vessel physiology and PCI planning tools.
2026-02
PR Newswire
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 late-breaking clinical trial demonstrated that CathWorks FFRangio showed similar clinical outcomes to invasive pressure wire-guided PCI through two years in the first-ever US cohort of over 4,000 patients.
2026-03
Cardiac Wire
Zero CAC QPA, Pre-Scan Nitroglycerin, and FFR Tech Validation
Cardiac Wire reported that the CathWorks FFRangiou2122 system met noninferiority to wire-based physiology for MACE at one year with statistically significant improvement in resource utilization and reduced procedure time, positioning it as a new standard in coronary physiology.
2026-07
CathWorks
Fourth Generation CathWorks FFRangiou00ae System Receives Regulatory Approval in Japan
CathWorks announced the approval of its fourth-generation FFRangiou00ae System by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), making it commercially available in Japan, the United States, and Europe. The system offers significant automation and enhancements with 93% diagnostic accuracy.
2022-10
CathWorks
CathWorks FFRangiou2122 System Receives U.S. FDA Clearance
CathWorks announced that its FFRangiou2122 System received United States Food & Drug Administration (FDA) 510(k) clearance, making it the first non-invasive device of its kind to receive FDA clearance for use during Percutaneous Coronary Intervention (PCI) assessment.
2018-12

Videos

Product demos, reviews, and walkthroughs for FFRangio.

View all on YouTube

Frequently Asked Questions

FFRangio integrates seamlessly into routine cath lab procedures by utilizing standard angiograms to generate fractional flow reserve (FFR) values, eliminating the need for invasive pressure wires and hyperemic agents. It provides real-time, comprehensive physiological assessment for the entire coronary tree, aiding in percutaneous coronary intervention (PCI) planning and optimizing clinical decision-making for patients with coronary artery disease.
The CathWorks FFRangio System has received U.S. FDA 510(k) clearance, Israel Amar approval, and Japan PMDA approval, and fulfills CE marking requirements. CathWorks is also ISO 13485 and 27001 certified, indicating adherence to quality management and information security standards. While specific details on patient privacy protocols beyond ISO 27001 are not explicitly detailed in the provided snippets, these certifications generally imply robust data security and privacy frameworks.
FFRangio has demonstrated high diagnostic accuracy, with a pooled analysis showing 93% accuracy compared to wire-based FFR. Clinical trials have also shown comparable one-year major adverse cardiac event (MACE) rates to invasive FFR, supporting its efficacy. It offers advantages by being non-invasive, reducing radiation exposure, and eliminating the risks associated with pressure wires and hyperemic agents, which other angiography-based FFR alternatives may also aim to do.
Studies suggest that FFRangio offers economic advantages by significantly reducing overall costs compared to invasive wire-based FFR, including decreased resource utilization in the catheterization lab. By streamlining procedural workflow and potentially reducing procedure time, it can lead to increased efficiency for healthcare providers.
While FFRangio offers significant benefits, the quality of the angiogram and the projections used are crucial for the accuracy of the algorithm's output. The feasibility of measuring FFR derived from coronary angiography in an all-comers population in real clinical practice can still be controversial, despite promising results in clinical trials. Additionally, its diagnostic performance immediately after PCI has not been established.

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View company profile →

Suggest an Edit → | 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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