FlashAngio caFFR System

The FlashAngio caFFR System from RainMed Medical provides non-invasive coronary functional assessment by calculating fractional flow reserve (FFR) values directly from standard coronary angiography images. This approach eliminates the need for pressure guidewires and hyperemic agents traditionally required for FFR measurement.

Product Overview

Fractional flow reserve has become an important metric for guiding percutaneous coronary intervention (PCI) decisions, helping clinicians determine whether coronary artery stenosis is functionally significant enough to warrant treatment. Traditional guidewire-based FFR measurement requires inserting a pressure-sensing guidewire across the stenosis and administering adenosine or other hyperemic agents to achieve maximum hyperemia.

The FlashAngio caFFR system calculates FFR computationally using only the angiographic images already acquired during standard diagnostic catheterization. This angiography-derived FFR (caFFR) approach offers advantages in workflow efficiency, patient safety, and cost reduction.

Key Features

The caFFR system’s CFD algorithm delivers FFR results in 2–3 minutes at 95.7% consistency with invasive guidewire measurements, without pressure wires or adenosine.

• Non-invasive measurement: No pressure guidewire insertion required
• No hyperemic agents: Eliminates adenosine-related contraindications and side effects
• Real-time calculation: FFR results available in 2-3 minutes from angiogram
• High accuracy: 95.7% consistency with guidewire-derived FFR
• Minimal workflow disruption: Does not require changes to standard catheterization procedures

Technical Specifications

Standard 2D angiography images feed a CFD algorithm that reconstructs 3D coronary geometry and returns FFR values within 2–3 minutes at 95.7% consistency versus guidewire FFR.

Clinical Applications

The caFFR system supports clinical decision-making in several scenarios:

Primary indications:

• Assessment of intermediate coronary stenosis (40-70% diameter stenosis)
• Multi-vessel coronary disease evaluation
• Serial lesion assessment within single vessels
• Post-PCI functional assessment

Procedure integration: The system integrates into existing catheterization laboratory workflows without requiring additional equipment positioning or patient preparation. Clinicians can obtain FFR values during the diagnostic angiography phase before deciding whether to proceed with intervention.

Regulatory Status

The system was among the first domestic Chinese FFR products to achieve international regulatory certification, enabling export to markets outside China.

Clinical Evidence

RainMed has collaborated with leading cardiovascular centers to generate clinical evidence supporting caFFR accuracy and clinical utility. Research findings have been published in peer-reviewed journals including Cardiovascular Research and JACC: Cardiovascular Interventions.

The validation studies demonstrate that caFFR provides clinically equivalent information to invasive guidewire-based FFR in the majority of cases, with the potential to reduce procedure time, radiation exposure, and consumable costs.

Market Context

FFR utilization in China remains significantly below developed markets. Data from 2020-2025 indicates FFR penetration rates of 22.5% in the United States, 17.2% in Japan, and 6.9% in the European Union, while China’s penetration remains below 0.4%. However, the compound annual growth rate of FFR products in China reached 97.9% during the same period, indicating substantial market expansion potential.

Frequently Asked Questions

How accurate is caFFR compared to guidewire FFR?

Clinical validation studies report 95.7% consistency between caFFR and guidewire-derived FFR measurements. The system uses computational fluid dynamics algorithms optimized for coronary hemodynamics.

What are the advantages of caFFR over guidewire-based FFR?

The main advantages include elimination of pressure guidewire costs, avoidance of hyperemic agent contraindications (adenosine can cause bronchospasm, bradycardia), reduced procedure time, and ability to assess multiple vessels from a single angiogram.

Is caFFR covered by insurance in China?

Coverage varies by province and hospital. The product is included in some regional medical device catalogs following NMPA approval.