FlashAngio caIMR System
The FlashAngio caIMR System represents the world’s first commercially approved non-interventional system for coronary microcirculation assessment. Developed by RainMed Medical, the system calculates the index of microvascular resistance (IMR) from standard angiography images without requiring pressure guidewires or hyperemic agents.
Product Overview
Coronary microvascular disease (CMD) affects a significant proportion of patients presenting with chest pain symptoms despite having non-obstructive coronary arteries. Traditional assessment of microcirculation using guidewire-derived IMR requires specialized equipment, hyperemic agents, and repeated saline injections—technical complexities that have limited its clinical adoption.
The caIMR system addresses these barriers by computing IMR values computationally from existing angiographic data, making microcirculation assessment accessible in routine clinical practice.
Key Features
Approved in China in April 2023 and validated at 93.81% accuracy in the Flash III trial, the caIMR system is the world’s first commercially approved non-invasive microcirculation diagnostic product.
- Non-invasive assessment: No pressure guidewire insertion required
- No hyperemic agents: Eliminates adenosine-related contraindications
- Dual evaluation: Provides microcirculation status in addition to epicardial assessment
- High accuracy: 93.81% accuracy demonstrated in Flash III clinical trial
- Integrated workflow: Compatible with standard catheterization procedures
Technical Specifications
For non-invasive microvascular assessment, caIMR derives the IMR value from standard angiography via CFD, validated at 93.81% accuracy in the Flash III pre-market study.
| Parameter | Specification |
|---|---|
| Input | Standard 2D coronary angiography images |
| Algorithm | Computational Fluid Dynamics (CFD) |
| Clinical Accuracy | 93.81% (Flash III study) |
| Measurement Type | Index of Microvascular Resistance |
| Integration | Standalone or combined with caFFR |
Clinical Applications
Primary indications:
- Assessment of coronary microvascular disease
- Evaluation of patients with angina and non-obstructive coronary arteries (INOCA)
- Prognostic stratification following acute myocardial infarction
- Pre- and post-PCI microcirculation evaluation
Clinical significance: Guidelines including the Chinese Expert Consensus on Diagnosis and Treatment of Coronary Microvascular Diseases (2017) and the Chinese Multidisciplinary Expert Consensus on Diagnosis and Treatment of Microvascular Diseases (2020) recommend IMR assessment in patients with coronary heart disease. The caIMR system makes this assessment feasible in routine clinical settings.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | April 2023 |
| European Union (CE) | Not Yet Applied | - |
| United States (FDA) | Clinical Study Phase | - |
The system entered the NMPA special approval channel for innovative medical devices, reflecting recognition of its novel approach and clinical value. The FDA has classified caIMR as a Class III medical device with clinical studies underway for potential US market clearance.
Clinical Evidence
The Flash III pre-market clinical study demonstrated 93.81% accuracy for the caIMR system in coronary microcirculation assessment. This validation establishes the system as a clinically reliable alternative to invasive guidewire-based IMR measurement.
Research has confirmed that combining FFR and IMR provides full functional evaluation from epicardial coronary arteries to intramyocardial microcirculation. The caFFR and caIMR systems together offer this complete assessment capability non-invasively.
Technology Differentiation
Traditional guidewire-derived IMR measurement requires:
- Pressure-sensing guidewire insertion
- Hyperemic agents (adenosine)
- Repeated normal saline injections
- Specialized equipment and training
- Extended procedure time
These requirements have historically limited IMR to research settings rather than routine clinical practice. The caIMR system removes these barriers while maintaining clinical-grade accuracy.
Strategic Positioning
As a core module of RainMed’s FlashBot vascular interventional robot platform, caIMR is designed for future integration into automated surgical workflows. Together with caFFR, the system provides the “diagnostic brain” that enables surgical robots to assess coronary physiology and guide treatment decisions.
Frequently Asked Questions
What is the difference between caFFR and caIMR?
caFFR measures fractional flow reserve (FFR) to assess epicardial coronary artery stenosis, while caIMR measures the index of microvascular resistance (IMR) to evaluate coronary microcirculation. Together they provide full coronary functional assessment.
Is caIMR approved by the FDA?
The FDA has classified caIMR as a Class III medical device. Clinical studies are underway for potential FDA clearance. Currently, the system is only approved for commercial use in China (NMPA).
When did caIMR receive NMPA approval?
The FlashAngio caIMR System received NMPA approval in April 2023, becoming the first non-invasive coronary microcirculation diagnostic product to achieve market authorization in China.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.