FFRangio System
by CathWorks (acquired by Medtronic)
· Based in Israel →
— A quick, reliable intraprocedural physiologic assessment for the entire coronary tree.
Contact vendor for pricing information.
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 uses AI and advanced computational science to analyze routine angiograms and create a detailed 3D model of the coronary arteries. This model identifies the location and severity of blockages and calculates Fractional Flow Reserve (FFR) values for the entire coronary tree, including side branches. This wire-free and drug-free approach provides a comprehensive physiological assessment of coronary artery disease (CAD), aiding in the evaluation of stenosis and optimizing PCI decisions.
Cardiac CT/MRI Analysis
While the FFRangio System primarily utilizes routine angiograms (X-rays) for its analysis, other AI-powered tools in cardiology, such as CT-FFR analysis, are used to analyze cardiac CT scans to produce 3D images for assessing blood flow restriction and plaque analysis.
Arrhythmia Detection Accuracy
The FFRangio System is focused on the physiological assessment of coronary artery disease and does not have reported features for arrhythmia detection or analysis. Other AI applications exist for ECG data analysis to predict conditions like congestive heart failure and identify critical arrhythmias.
AHA/ACC Guideline Alignment
The use of FFR to guide treatment decisions is supported by guidelines, and the FFRangio System aims to increase the utilization of physiological assessment in line with these recommendations by offering a less invasive and faster method.
Real-Time Alert Capability
The FFRangio System provides quick and reliable intraprocedural FFRangio values, enabling physicians to make real-time decisions during procedures. It offers real-time FFRangio values at every point on the coronary tree and a simulated pullback curve to differentiate functional patterns of CAD.
Physician Tip
The FFRangio System offers a wire-free and drug-free method for comprehensive physiological assessment of coronary artery disease using routine angiograms. This can lead to quicker and more comprehensive clinical assessments, potentially reducing procedure time and patient discomfort. The system's ability to provide FFR values for the entire coronary tree and tools like lesion impact analysis can optimize clinical decision-making and PCI planning. It has demonstrated high diagnostic accuracy compared to wire-based FFR. Consider its use to streamline workflow in the cath lab and potentially improve resource utilization.
The FFRangio System is designed for seamless integration into the cath lab workflow. It utilizes routine angiograms and integrates with existing cath lab imaging, including PACS. The system transforms angiograms into a 3D model, and its AI aids in quick angiogram analysis.
Details
| Category | Cardiology AI, Surgical AI |
| Pricing | Contact vendor for pricing information. |
| Deployment | SaaS, on-prem, hybrid |
| Training | Unknown |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology |
Support & Reliability
| Training Provided | Unknown |
What the Web Says
The CathWorks FFRangio System is an AI-powered, non-invasive tool that assesses coronary artery disease using routine angiograms, eliminating the need for invasive pressure wires and drug stimulation. It provides comprehensive multi-vessel coronary physiology and PCI planning tools. Physicians and studies generally indicate high diagnostic accuracy and comparable clinical outcomes to traditional invasive methods.
Overall: PositiveStrengths
- Non-invasive, wire-free, and drug-free approach.
- High diagnostic accuracy (93%) compared to invasive FFR.
- Comparable one-year major adverse cardiac event (MACE) rates to invasive FFR.
- Provides comprehensive multi-vessel coronary physiology and PCI planning tools.
- Reduces procedure time, radiation exposure, and contrast dye usage.
- Strengthens team-based aspects of procedures by allowing non-physician staff to initiate the process.
Limitations
- Safety and effectiveness not established in pediatric patients.
- FFRangio results may be adversely affected by marginal quality imaging data.
- May identify more artery narrowing, potentially leading to more stent placements.
- Questions about accuracy for complex anatomy (left main, bifurcations, grafts) are still under investigation.
- Some operators may still have a gap in confidence compared to wire-based FFR.
Based on reviews from: PR Newswire, CathWorks, Medtronic, YouTube (Medtronic), HealthAidb — Software, The ALL-RISE Trial: FFRangio and the Next Step in Coronary Physiology, Cardiovascular News, Insights from Dr. Rahul Sharma's CVIT 2021 Presentation, Stanford Medicine, Do the Angiographically-Derived FFR Systems Have a Class Effect?, Canada Newswire
Last updated: 2026-10-18
Ratings & Reviews
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Press & Coverage
PR Newswire
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, presented at ACC.26 and published in the New England Journal of Medicine, showed that the CathWorks FFRangio System achieved similar one-year clinical outcomes to invasive pressure wire guidance for coronary artery disease, with added benefits of improved resource utilization and reduced procedure time.
2026-03
Medtronic
Medtronic completes acquisition of CathWorks, expanding its leadership in transforming care for patients with cardiovascular disease
Medtronic completed its acquisition of CathWorks for $585 million, integrating the FFRangio System into its cardiovascular portfolio. This acquisition follows a 2022 strategic partnership and aims to redefine cardiovascular care through AI and advanced computational science.
2026-04
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 presented a US cohort of over 4,000 CathWorks FFRangio patients, demonstrating similar clinical outcomes to invasive pressure wire-guided PCI over two years. This study reinforces the system's effectiveness in diagnosing and treating coronary artery disease.
2026-03
PR Newswire
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), specifically highlighting the CathWorks FFRangio System's unique AI and computational science approach for coronary physiologic assessment.
2026-02
DAIC
Randomized Controlled Trial on AI FFRangio Technology Presented at TCT | DAIC
The PROVISION Study, the first Japanese prospective randomized controlled trial, demonstrated that the FFRangio System yielded similar clinical treatment plans and prognoses to invasive wire-based FFR, with economic and resource utilization advantages.
2024-10
CathWorks
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 2017/745 (EU MDR), fulfilling CE marking requirements. The technology was also prominently featured at the EuroPCR conference.
2024-05
Chan Soon-Shiong Medical Center at Windber
CSSMCW Adopts Innovative CathWorks FFRangio System - Chan Soon-Shiong Medical Center at Windber
Chan Soon-Shiong Medical Center at Windber (CSSMCW) adopted the CathWorks FFRangio System, a computer-based technology that uses AI and computational science to create 3D models of coronary arteries from angiograms, improving diagnostic efficiency and patient experience.
2024-05
CathWorks
Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan
CathWorks announced the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved its fourth-generation FFRangio System, which is also available in the US and Europe. This system provides a comprehensive physiologic assessment of coronary artery disease without invasive pressure wires or hyperemic agents.
2022-10
Videos
Product demos, reviews, and walkthroughs for FFRangio System.
How Does FFRangio Work? - Highlight from Dr. Rahul P. Sharma's CVIT 2021 Presentation
CathWorks
CathWorks FFRangio System Teaser
CathWorks
Dr. Rahul P. Sharma introduces the CathWorks FFRangio System - CVIT 2021
CathWorks
The CathWorks FFRangio System - Example Analysis
CathWorks
Medtronic and CathWorks Announce Co-promotion Partnership For FFR-based Technology For CAD
Radcliffe Cardiology
CathWorks - Overview
MedTech Innovator
Frequently Asked Questions
The FFRangio System employs AI algorithms to analyze standard angiographic images, generating a non-invasive fractional flow reserve (FFR) equivalent. It provides metrics such as vessel-specific FFR values and 3D coronary artery reconstructions, aiding in the physiological assessment of stenosis severity without the need for a pressure wire.
The FFRangio System has received regulatory clearances, including FDA clearance and CE Mark, for its use in assessing coronary artery disease. Clinical studies have demonstrated a strong correlation and good agreement between FFRangio-derived FFR values and invasively measured FFR, supporting its diagnostic accuracy.
Alternatives include stress testing (e.g., exercise, pharmacological), cardiac CT angiography with FFRCT, and traditional invasive FFR. FFRangio offers a streamlined workflow by utilizing existing angiographic images, potentially reducing patient risk and discomfort associated with additional invasive procedures or radiation exposure from dedicated CT scans.
Pricing structures for the FFRangio System can vary, often involving per-procedure fees or subscription-based models. Reimbursement pathways are evolving, with codes typically aligning with existing angiography procedures, and specific coverage may depend on regional and national healthcare policies.
Limitations of the FFRangio System can include challenges in accurately assessing highly complex anatomies such as severely calcified vessels, ostial lesions, or diffuse disease, where image quality or AI interpretation may be impacted. Its performance in specific patient populations or very unusual anatomies may also require careful consideration.
The FFRangio System is designed for seamless integration with existing cath lab angiography systems and Picture Archiving and Communication Systems (PACS). It typically requires a secure network connection for data transfer and processing, adhering to standard healthcare IT security protocols to ensure patient data privacy and system integrity.
Training for the FFRangio System typically involves a short learning curve for cardiologists and cath lab staff, focusing on image acquisition best practices and interpretation of the AI-generated FFR values and visualizations. The company usually provides comprehensive training programs, ongoing technical support, and educational resources to ensure proficient and confident use.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18