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RainMED
CaFFR

CaFFR

New approach getting precision

CaFFR

CAFFR™

Innovative Delivery System

  • icon
    Get More Assurance
    • No need to guess the state of hyperemia.
    • To provide better correlation, top accuracy and faster calculation.
    • To get more assurance to cardiologists.
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    Get More Guidance
    • Monitoring real-time aortic pressure in all stages of cardiac cycle.
    • Assessing more physiology parameters simultaneously to supply guidance for all diversified cases.
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    Get More Assurance
    • No adenosine, guidewire required, wedging or drifting.
    • Better connection and equilization
    • CAFFR procedure can be fluently integrated in cath lab’s workflow.
    • Easily deployed anywhere, FlashAngioTM will free up more operation from cardiologist.
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    Free Up Your Time
    • Dedicated designed CFD algorithm offers resolution to Navier–Stokes formula in 30 seconds.
    • No need to balance risk for applying FFR.
    • With FlashAngioTM, FFR is always available whenever and wherever you want it, without time-consuming setup or connecting of cables.

A Milestone of FFR Analysis

CaFFR

Guided Procedures

  • Ceraflex

    1. Obtaining the 3D model of the blood vessels and calculating blood flow velocity based on angiographic image.

  • Ceraflex

    2. Using enhanced CFD approach to measure FFR value, get data in seconds.

  • Ceraflex

    3. Simplified live case documentation with vessel 1 and procedure step annotation.

FAME

  • Allows more accurate identification of hemodynamically relevant stenosis.(1)
  • Reduces mortality and myocardial infarction by 34% at two years.(2)
  • Reduces the amount of contrast media used and lower the general cost.(3)
  • Improves outcomes and patient quality of life.(4)
  • No increase in procedure time.

FAME Ⅱ

  • The MACE happened to FFR-guided PCI group were significantly lower than the medical therapy group.(3)(4)
  • 86% relative reduction in the risk for ACS requiring unplanned hospital readmission with urgent revascularization.
  • Greater relief of angina.
  • Cost-effectiveness-ICER of $32,000 per QALY
CaFFR

Study Result

  • Patients with moderate stenosis (50-70% Stenosis) .1/3 of them will be ignored by angiography alone.
  • Patients with severe stenosis (>70% Stenosis). 20% of them will be over treated by angiography alone.

Supported By Guidelines

  • FFR was awarded the highest level of evidence, Class I, level of Evidence a, by the European society of Cardiology (ESC) and the European association for Cardio-thoracic surgery (EACTS).(5)
  • The ACC/AHA/SCAI guidelines are Class II a, level of Evidence a, for determining whether PCI of a specific coronary lesion is warranted.(6)

(1) Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. FAME study. N Engl J Med. 2009;360(3):213-24.

(2) Angiographic Versus Functional Severity of Coronary Artery Stenoses in the FAME Study : Fractional Flow Reserve Versus Angiography in Multivessel Evaluation. Journal of the American College of Cardiology, 2010, 55(25):2816-21

(3) Fearon WF. FAME 2 Cost-effectiveness: A Prospective, Randomized Trial Evaluating the Cost-effectiveness of FFRGuided PCI in Patients with Stable Coronary Artery Disease Presented at Late Breaking Clinical Trials 1 at TCT 2012, Miami, Florida, October 24, 2012.

(4) De Bruyne B, Pijls N, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11):991-1001.

(5) Wijns W, Kolh P, danchin n, et al. Guidelines on myocardial revascularization: the task Force on Myocardial Revascularization of the European society of Cardiology (EsC) and the European association for Cardio-thoracic surgery (EaCts). Eur Heart J. 2010;31(20):2501-55.

(6) Kushner FG, hand M, smith sC Jr, et al. 2009 focused updates: aCC/aha guidelines for the management of patients with st-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and aCC/aha/sCaI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update)

More than FFR

Unique multi-functionality with proprietary sensor chip technology enables assessment of multiple parameters with FlashPressureTM, the real-time measure sensor capable of simultaneous assessment of FFR, CFR and IMR and cFFR in all sector of one cyble Pd/Pa.

Ceraflex Ceraflex

Superior Accuracy of CAFFRTM

FlashAngioTM demonstrated best correlation to FFR measurement in lately cliniDuring standardized testing, FlashAngioTM running time is within 30s, and get the results(8)

91% for FFR values between 0.75-0.85. The sensitivity and specificity were 92% and 98%, respectively.

Balloon Material Rainmed CAFFR Cathworks FFRangio Medis QFR
Double balloon materials 96% 92% 88%(7)

(7) Jelmer Westra,Diagnostic Accuracy of On-line Quantitative Flow Ratio Functional Assessment by Virtual Online Reconstruction: FAVOR 2 Europe-Japan,2017.

(8) Yong Huo, Jianping Li, Yanjun Gong,et.al. Accuracy of Angiography-Based Fractional Flow Reserve from A SpeciallyDesigned Computational Fluid Dynamic MethodJournal of the American College Cardiology.2010;55(25):2018-21.