Medis QFR® Quantitative Flow Ratio

Quantitative Flow Ratio (QFR) from Medis Medical Imaging offers a novel, safe1, non-invasive approach to physiology designed to enhance procedural efficiency2, drive economic value* and improve the patient’s procedural
experience**.

Interested in learning more?

Contact a rep to learn more about MEDIS QFR.

Supported by extensive clinical evidence and a large number of trials and publications3

Excellent correlation and accuracy compared to FFR4
Strong diagnostic performance compared to iFR5
Performed in more than
12,000 patients and
16,000 vessels3
Peer-reviewed in more
than 85 publications3

How it works

A 3D model is reconstructed from two angiography images to calculate QFR.

You are then presented with
physiological and anatomical
information on one screen.

Benefits

Improve patient experience** and delivery efficient workflow.

Improved patient experience**

Safe1, accurate4 & streamlined workflow

Cost savings*

References

  1. Arturo Cesaro, et al; Fractional assessment of coronary stenosis; An overview of available techniques. Is quantitative flow ratio a step to the future? 2018 July 11.
  2. Westra J, Andersen BK, et al; Diagnostic performance of in-procedure angiography-derived Quantitative Flow Reserve compared to pressure-derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc 2018.
  3. Data on file. 35-100018.
  4. Choi et al. Clinical relevance and prognostic implications of contrast quantitative flow ratio in patients with coronary artery disease. International Journal of Cardiology. Sept 2020.
  5. Emori H, Kubo T, Ket al; Quantitative flow ratio and instantaneous wave-free ratio for the assessment of the functional severity of intermediate coronary artery stenosis. Coronary Artery Disease 2018.

 

* Reduced side effect profile when compared to FFR with adenosine induced hyperemia

** Cost savings based on the reduced cost of QFR compared to conventional FFR and the respective cost of administration of hyperemic agent (adenosine) and additional invasive proce dural resources

QAngio XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QAngio XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QAngio XA 3D provides:

Intended Use

Indications For Use

QAngio XA 3D is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QAngio XA 3D are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

Limitations

The two 2D angiographic images used for the 3D vessel reconstruction need to be taken with at least 25 degrees difference in viewing angle.
QFR measurements have not been evaluated for non-coronary arteries, pediatric patients, and cardiac patients with the following conditions:
nor for the following lesions and vessels:
QFR measurements cannot be performed accurately under the following conditions:

WARNINGS

QAngio XA 3D must be used by cardiologists or trained technicians who are qualified to perform cardiac analysis. If the analysis results are used to reach a diagnosis, the results must be interpreted by a qualified medical professional. In clinical practice QAngio XA 3D should not be used for purposes other than those indicated in the section Intended Use.
Users must have sufficient proficiency in the selected operating language, read this manual, become familiar with the software, and must be certified by Medis before using QAngio XA 3D in a clinical environment in order to obtain reliable analysis results.

Note on Monitor Aspect Ratio and Resolution

The shapes of objects and calipers displayed may get slightly distorted when the resolution is set to an aspect ratio different than the monitor’s physical aspect ratio. This distortion does NOT affect the accuracy of measurements or analyses. To avoid distortion, set the resolution of the monitor to an aspect ratio equal to the physical aspect ratio. LCD monitors typically operate best at their native resolution. Microsoft Windows recommends a resolution when it has sufficient information to do so.

North American Regulations

QAngio XA 3D has been cleared for market in the United States by the FDA (Food and Drug Administration) under the provisions of Section 510(k) of the Food, Drug, and Cosmetic Act.

Caution

Federal law restricts this device to sale by or on the order of a physician.