FFRangio System
Contact for pricing
Regulatory Status Disclosed
Overview
The CathWorks FFRangio System is an AI-powered medical tool designed for the physiological assessment of coronary artery disease (CAD) using routine angiograms. It is intended for use by interventional cardiologists and other specialists in catheterization laboratories.
- What it does: The system utilizes artificial intelligence and computational science to transform standard 2D angiograms into a 3D model of the coronary tree. From this model, it calculates Fractional Flow Reserve (FFR) values at various points along the coronary arteries, providing a comprehensive physiological assessment without the need for invasive pressure wires or drug stimulation.
- Who it is for: The FFRangio System is for interventional cardiologists and other healthcare professionals managing patients with CAD in cath lab settings.
- How it fits a clinical or practice workflow: The system integrates into the existing cath lab workflow, beginning with routine diagnostic angiograms. The angiographic images are transferred to a console where AI software assists in analyzing the views and automatically tracing coronary arteries. The system then provides FFRangio values, a simulated pullback curve, and an integrated sizing tool to aid in clinical decision-making and PCI planning. This process is designed to streamline procedural workflow and optimize clinical decision-making.
- Notable capabilities: Key capabilities include real-time FFRangio values across the entire coronary tree, a simulated pullback curve to differentiate functional patterns of CAD, and an integrated sizing tool for non-invasive lesion measurements. It also features a “Lesion Impact” tool, which allows for the assessment of residual ischemia by virtually excluding a lesion. The system aims to provide a wire-free and drug-free FFR assessment.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time FFRangio values at every point on the coronary tree
- Simulated pullback curve differentiates functional patterns of CAD
- Lesion Impact feature to assess residual ischemia
- Integrated sizing tool for non-invasive lesion measurements
- Intuitive user interface
- Artificial intelligence aids in quick angiogram analysis
- Seamless integration with cath lab boom and PACS
- Eliminates the need for invasive pressure wires, drugs, or a guide catheter
- Approximately 20% reduction in radiation compared to wire-based physiology
- Provides a 3D reconstruction of the entire coronary tree
Use Cases
- Optimizing Percutaneous Coronary Intervention (PCI) therapy decisions
- Comprehensive physiological assessment of coronary artery disease (CAD)
- Procedural planning for PCI
- Differentiating diffuse from focal coronary artery disease
- Evaluating clinical significance of coronary lesions
- Reducing risks and costs associated with invasive Fractional Flow Reserve (FFR)
What Physicians Need to Know
Coronary Artery Assessment
The FFRangio System utilizes artificial intelligence (AI) and advanced computational science to derive Fractional Flow Reserve (FFR) values from routine angiograms (X-rays), providing a wire-free and drug-free physiological assessment of the entire coronary tree. It offers multivessel FFR values, simulated pullback curves to differentiate functional disease, and tools for PCI planning, including lesion impact assessment and integrated sizing.
Diagnostic Accuracy
The system has demonstrated excellent diagnostic accuracy, with a pooled analysis of five prospective studies, including the FAST-FFR pivotal study, showing 93% accuracy when compared to invasive wire-based FFR. The FAST-FFR trial reported sensitivity of 93.5% and specificity of 91.2%.
Real-Time Assessment
FFRangio provides real-time FFRangio values at every point on the coronary tree during procedures, offering immediate physiological insights to facilitate faster clinical decision-making.
AHA/ACC Guideline Alignment
The FFRangio System supports physiology-guided revascularization, which is a recommended approach by guidelines for assessing intermediate coronary lesions. Clinical outcomes with FFRangio-guided treatment have been shown to be comparable to invasive FFR.
Physician Tip
The FFRangio System offers a non-invasive, efficient, and comprehensive physiological assessment of coronary artery disease directly from routine angiograms, eliminating the need for pressure wires and hyperemic agents. This can streamline workflow, reduce patient discomfort and procedural time, and potentially expand the utilization of FFR-guided decision-making in the cath lab. Its tools for multivessel analysis, simulated pullback, and PCI planning can optimize treatment strategies for complex cases.
The FFRangio System is designed for seamless integration within the catheterization lab workflow, compatible with major C-Arm machines and PACS systems. It leverages artificial intelligence and advanced computational science to process angiographic images and deliver FFR values intraprocedurally. The technology has received FDA clearance and is commercially available in the United States, Europe, and Japan.
Details
| Category | Cardiology AI, Surgical AI |
| Pricing | Contact for pricing — Contact for pricing |
| Deployment | On-premise (integrates with cath lab equipment and C-arm angiography systems) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The CathWorks FFRangio System received U.S. Food and Drug Administration (FDA) 510(k) clearance (K182149) on December 19, 2018. 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 |
What the Web Says
The FFRangio System by CathWorks is an AI-powered, non-invasive technology that assesses coronary artery disease using routine angiograms, aiming to eliminate the need for invasive pressure wires and drug stimulation. Physicians generally express positive opinions, highlighting its ease of use and efficiency in the cath lab. Clinical trials and expert opinions reinforce its diagnostic accuracy and comparable clinical outcomes to traditional wire-based FFR.
Overall: PositiveStrengths
- Non-invasive, eliminating the need for pressure wires, anticoagulation, or hyperemic agents.
- Provides quick and reliable intraprocedural FFRangio values for the entire coronary tree.
- Improved workflow efficiency and ease of use for cath lab teams.
- Comparable clinical outcomes to invasive FFR at one year.
- Offers comprehensive multi-vessel coronary physiology and PCI planning tools, including a simulated pullback curve and integrated sizing tool.
- Reduced radiation exposure and less use of contrast medium compared to wire-based methods.
Limitations
- Diagnostic performance has not been established for lesions immediately after PCI.
- Requires quality angiograms for effective analysis.
- Initial learning curve for staff, though mitigated by good representative support.
- Lesion Impact feature not approved in all geographies or available for all case types (e.g., Diagonal and Ramus).
- Some early versions were perceived as time-consuming, though newer versions have improved efficiency.
- If the lesion is not visible on the angiogram, it's difficult for the technology to derive an FFR value.
Based on reviews from: CathWorks, American Heart Association Journals, PR Newswire, HealthAidb, TCTMD Physician Roundtable (YouTube), Stock Titan
Last updated: 2026-07-18
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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 the CathWorks FFRangio System achieved non-inferiority to invasive pressure wire guidance for major adverse cardiac events at one year, while also showing improved resource utilization and reduced procedure time. These results were simultaneously published in the New England Journal of Medicine.
2026-03
American Heart Association Journals
Realu2010World Outcomes of FFRangiou2010Guided Treatment for Coronary Artery Disease in Acute Versus Chronic Coronary Syndromes - American Heart Association Journals
This study, published in the Journal of the American Heart Association, found that FFRangio-guided treatment in a real-world setting yielded two-year outcomes comparable to wire-based fractional flow reserve for both acute and chronic coronary syndromes. The FFRangio system is approved for clinical use in the United States, Japan, and Israel.
2026-05
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
A late-breaking clinical trial presentation revealed that the first U.S. cohort of over 4,000 CathWorks FFRangio patients demonstrated similar clinical outcomes to invasive pressure wire-guided PCI through two years. The FFRangio System uses AI and computational science to provide physiological information from angiograms, eliminating the need for invasive pressure wires.
2026-03
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 role of angiography-derived physiology (ADP), highlighting the CathWorks FFRangio System's ability to provide comprehensive multi-vessel coronary physiology and PCI planning tools. The opinion notes FFRangio's excellent diagnostic accuracy and comparable one-year MACE rates to invasive FFR.
2026-02
CathWorks
As Featured in Cardiac Wire: CathWorks FFRangio Goes Beyond Physiology
This article from Cardiac Wire discusses how the CathWorks FFRangio System addresses the underutilization of traditional wire-based coronary physiology by offering a more convenient and less time-consuming method. The FFRangio System has received regulatory clearances in the US, Israel, and Japan, and fulfills CE marking requirements.
2025-12
PubMed (EuroIntervention)
FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial - PubMed
This publication outlines the design and rationale of the multicenter, randomized ALL-RISE trial, which aims to compare clinical outcomes, resource utilization, and cost-effectiveness of FFRangio-guided PCI versus pressure wire-based approaches. The trial seeks to provide prospective data on the safety and efficacy of FFRangio for coronary lesion assessment.
2025-08
CathWorks
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
The PROVISION Study, the first Japanese prospective randomized controlled trial comparing angio-based physiology technology to invasive wire-based physiology, met its primary endpoint, demonstrating similar clinical outcomes for FFRangio and FFR. The study also revealed significant economic and resource utilization advantages for FFRangio.
2025-05
PR Newswire
CathWorks Announces EU MDR Approval, Prominent Presence at EuroPCR and Full Launch of Co-promotion
CathWorks announced that its FFRangio System received approval under the European Union Medical Device Regulation (EU MDR), fulfilling the requirements for CE marking. This approval coincides with a prominent presence at the EuroPCR conference and the full launch of a co-promotion partnership with Medtronic.
2024-05
Videos
Product demos, reviews, and walkthroughs for FFRangio System.
Introducing The CathWorks FFRangiou2122 System
CathWorks
The (R)evolution of Image-based FFR u2013 Introducing the CathWorks FFRangio System
CathWorks
Dr. Rahul P. Sharma introduces the CathWorks FFRangio System - CVIT 2021
CathWorks
How Does FFRangio Work? - Highlight from Dr. Rahul P. Sharma's CVIT 2021 Presentation
CathWorks
Dr. Rahul P. Sharma Introduces the CathWorks FFRangio System - Highlight from CVIT Presentation
CathWorks
Physiology Redefined - Learn About the New Era in Physiology with the CathWorks FFRangio System
CathWorks
Frequently Asked Questions
The CathWorks FFRangio System utilizes artificial intelligence and advanced computational science to derive Fractional Flow Reserve (FFR) values from routine diagnostic angiograms. This eliminates the need for invasive pressure wires and drug-induced hyperemia, streamlining the procedure, reducing patient discomfort, and providing comprehensive physiological assessment for informed treatment decisions.
The CathWorks FFRangio System has received FDA clearance as a software device for quantitative and qualitative analysis of angiography DICOM data to support functional evaluation of coronary artery disease. Healthcare organizations must ensure local validation of AI tools within their specific deployment context and adhere to evolving regulations regarding AI use, data privacy (HIPAA), and patient consent.
While highly accurate, AI-FFR technology may face challenges in complex lesions, such as severely calcified vessels, where its accuracy might be less than traditional pressure wire measurements. Efficacy is also directly correlated to the amount of training data, and performance can be limited by factors like image noise or artifacts.
FFRangio offers a non-invasive alternative to traditional wire-based FFR by using existing angiogram images, thus avoiding the risks, costs, and time associated with pressure wires and hyperemic agents. It has demonstrated high diagnostic accuracy comparable to wire-based FFR and provides real-time, multi-vessel FFR values across the coronary tree, which can be more comprehensive than some other methods.
While specific pricing varies, AI-based FFR systems like FFRangio aim to reduce overall healthcare costs by decreasing unnecessary invasive procedures and optimizing treatment. Medicare has established reimbursement for AI-enabled FFR technologies, which can influence adoption and overall spending patterns.
The FFRangio System is designed for seamless integration into the cath lab workflow and is generally easy for clinicians to adopt with limited training. Usability testing has shown that healthcare personnel, including physicians, nurses, and technicians, can complete critical tasks without errors after appropriate training.
As a medical device processing patient data, the FFRangio System must adhere to strict data privacy and security protocols, including HIPAA compliance. Healthcare providers are responsible for ensuring robust data protection, including encryption, access controls, and secure handling of protected health information when using AI systems.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18
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