NiFFR

Non-invasive Fractional Flow Reserve ” NiFFR “

NiFFR

Non-invasive Fractional Flow Reserve developed by the Coronary Artery Stenosis Evaluation Software Produced by Mobtakeran Salamat Fakher company is a software that accurately simulates the physiologic coronary blood flow allowing for meaningful qualitative assessment of coronary artery perfusion. Our Coronary Artery Stenosis Evaluation Software draws upon mathematical equations and algorithms to accurately and reliably estimate the FFR. This software provides a non-invasive method of estimating FFR, Wall Shear Stress (WSS), and Index of Microvascular Resistance (IMR) using standard angiographic images. Using this software not only eliminates the need for a pressure wire and adenosine but also makes the procedure shorter and far less invasive since it eliminates the need for catheter advancement past the stenotic lesion. NiFFR is hence a safer, more convenient and more cost-effective method for evaluation of coronary artery disease in intermediate and borderline cases.

The claimed benefits of NiFFR

A: Analysis is done using standard X-ray angiography images with the need for three additional views and adenosine injection.

B: Like FFR, it allows accurate evaluation of stenotic lesions responsible for cardiac ischemia but reduces the need for invasive FFR.

C: It reduces the need for unnecessary revascularization by reliably identifying physiologically significant stenotic lesions (responsible for ischemic damage) as opposed to the lesions with less physiological significance.

D: It reduces the need for unnecessary revascularization by reliably identifying physiologically significant stenotic lesions (responsible for ischemic damage) as opposed to the lesions with less physiological significance.

E: It reduces the cost burden associated with inconclusive and inaccurate diagnostic studies.

F: It reduces the number of staff and procedure time, and also helps the physicians to avoid unnecessary procedures.

We will further expand on the meaning and significance of IMR and WSS measures.

Result Reserve

Computation of NiFFR was performed online, using a computational simulation service. In the first step, two diagnostic angiographic projections, at least 25 apart, were selected.

The NiFFR: frame count analysis was performed separately on the two angiographic projections that were acquired during hyperemia.

Our company conducted a literature search on the diagnostic accuracy of NiFFR and the existing tests in the current treatment pathway for patients with coronary artery disease, against a reference standard of invasive FFR testing. the company presented diagnostic accuracy per-patient results for NiFFR compared with:

* Heart Flow FFR-CT

* Single-Photon Emission CT (SPECT)

* Stress Echocardiogram (ECHO)

* Magnetic Resonance Imaging (MRI)

Compared with Invasive FFR

Pearson correlation was used to evaluate the correlation between NiFFR and FFR. The NiFFR (correlation coefficient r=0.70, p<0.001) showed strong correlation with FFR for 245 patients (multi-center).

NiFFR (Mean difference -0.02444, Standard deviation 0.06162) demonstrated slight but non-significant differences as compared with FFR in assessing significance of stenosis.