Medis QFR®

Medis QFR®

Physiology made simple.

Medis QFR® is a robust “workhorse” software solution for assessing angiography-derived physiology in patients with epicardial artery disease. Powered by AI and deep learning, Medis QFR® facilitates a streamlined workflow, enabling fast real-time and offline assessments. Scientifically proven, Medis QFR® stands as the foremost  image-based solution for evaluating coronary obstructions from angiograms

Navigate your daily clinical practice with Medis QFR®

From assessing coronary lesions to determining optimal treatment strategies and more*

Pre-PCI

Analyze efficiently

Efficiently evaluate coronary lesions for severity and morphology, guiding informed decisions on intervention or safe deferral.

During PCI

Optimize Confidently

Confirm lesion severity with QFR®’s precise measurements, adding an extra layer of accuracy and confidence to interventions.

Post-PCI

Evaluate Safely

Judge treatment outcomes confidently using QFR®’s proven insights, prioritizing patient safety and positive outcomes.

Simple

Simpler Intuitive workflow, applicable for online and offline usage.

Fast

No pressure wire, no hyperaemic agent, reducing treatment costs and procedure time.

Proven

Evidence from over 17.000 patients and 20.000 lesions across 200+ peer-reviewed articles.

Medis QFR® reimbursement approval in Japan!

We are thrilled to share with you exciting news: Medis QFR® has received approval for reimbursement by the Japanese Ministry of Health (MOH) as per January 1st 2024, marking a significant milestone in the field of interventional cardiology in Japan.

Your innovative solution for accurate coronary assessment

3D Vessel Reconstruction

Lumen Diameter

Angiographic Projection 1

Angiographic Projection 2

QFR Pullback with focal disease

Quantitative Lesion Assessment

Medis QFR® utilizes two angiographic projections for the quantitative assessment of physiology in epicardial arteries. Arterial plaques are often eccentric, requiring at least two orthogonal views to evaluate a coronary artery lesion. This approach resolves the challenge posed by eccentric lesions that may be hidden with the use of a single angiographic view and mitigates the risk of vessel shortening associated with a single projection5.

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Image Acquisition
For optimal 3D vessel reconstruction, Medis QFR® requires only two projections. It is advisable that these captured projections be orthogonal, featuring minimal overlap within the target segment to ensure accurate reconstruction.
Quantitative Analysis

AI enabled end diastolic frame selection helps save valuable time and minimizes user variability during the analysis. Deep learning further helps ensure precise alignment between the two angiographic projections ensuring consistent and reliable measurements which leads to an accurate QFR assessment

QFR Assessment
Medis QFR® provides a complete assessment of the target segment including the 3D reconstruction of the segment and quantitative assessment, which includes lesion length, per lesion ∆QFR, %Stenosis and Residual QFR. The dQFR/ds further provides the local severity of a lesion in the analyzed segment establishing the presence or absence of Focal disease.

Exceptional performance

0 x
3-fold decrease in the risk of adverse events associated with a Post-PCI cut off value > 0.896
0 %
reduction in MACE compared to angiographic group after 2 years7
0 %
faster than wire-based FFR
guided approach8
“We have been using QFR® since 2022. It will streamline the Cath Lab workflow, increasing the pre and post adoption of coronary physiology. For me, the benefits of QFR® are both the cost effectiveness as well as the time efficiency.”

Dr. Yuhei Kobayashi

Interventional cardiologist / Cardiologist

“We are excited to launch Medis QFR® in the VA Connecticut Cardiac Catheterization Laboratory. This innovative technology helps us provide cutting-edge, guided care to our Veterans with coronary artery disease.”

Dr. Samit Shah

Interventional cardiologist / Cardiologist

This technique is simpler, safer and less expensive with equivalent outcomes and will conceivably be readily and widely adopted. Angiographically derived FFR, and specifically QFR®, should, in the future, be used routinely, reserving the invasive wire-based FFR approach for the challenging minority of cases where QFR® accuracy is questioned. 

Dr. Morton J. Kern

Interventional cardiologist / Cardiologist

“State-of-the-art approach in acute coronary syndrome targets on the “pancoronary risk”. This can be assessed easily, safely, and reproducibly by QFR®.”

Dr. David M. Leistner

Interventional cardiologist / Cardiologist

Logo Goethe University Frankfurt am Main
“I am a strong believer QFR® adds invaluable parameters to the diagnostic angiogram. This will move us to one test that will give us all the information.”

Prof. Andreas Baumbach

Interventional cardiologist / Cardiologist

“QFR® is a robust technology and it provides good diagnostic information and guiding information”

Dr. Niels Holm

Clinical Researcher

Unmatched clinical accuracy

QFR® stands out with its proven exceptional accuracy both in clinical settings and in the Core Lab

QFR® vs angiographic assessment

Diagnostic Performance of In-Procedure Angiography-Derived QFR Compared to Pressure-Derived FFR: FAVOR II Europe-Japan

“Online computation of QFR in the Cath Lab is clinically feasible and superior to angiographic assessment for evaluation of intermediary coronary artery stenosis using FFR as a reference standard”

Specificity
87%
Sensitivity
87%
AuC
92%

QFR® vs wire-based FFR

Quantitative Flow Ratio: Meta analysis & systematic review

“Excellent correlation and agreement between QFR and FFR was demonstrated. QFR value below the threshold of 0.80 optimally predicts functional significance of coronary stenosis.”

Specificity
89%
Sensitivity
84%
AuC
94%

QFR® vs wire-based iFR

Diagnostic Agreement of Quantitative Flow Ratio With Fractional Flow Reserve and Instantaneous Wave‐Free Ratio

“QFR showed excellent correlation and diagnostic performance for both invasive pressure–derived physiologic indices (FFR and iFR), regardless of clinical presentation.

Specificity
82%
90%
Sensitivity
80%
92%
AuC
88%
95%

Quantitative flow ratio (QFR) is the only angiography-based physiological index that has been prospectively validated and has already been demonstrated to be associated with improved clinical outcomes when used to decide upon coronary revascularization, compared with conventional angiography. – EuroIntervention 2023: Expert Consensus  

The state of the art in non-invasive coronary physiology by Dr. Samit Shah at TCT 2023

Dr. Samit Shah, renowned from Yale School of Medicine & New Haven VA, delivered an insightful overview of angiography-based physiology at the recent TCT 2023 conference. Dr. Shah highlighted the transformative potential of non-invasive coronary physiology (NCP), with Medis QFR® in reshaping the diagnosis and treatment of coronary artery disease.

The impact of Medis QFR® on Clinical Decision-Making by Dr. Yuhei Kobayashi at TCT 2023

At TCT 2023, Dr. Yuhei Kobayashi, MD showed the transformative power of Medis QFR® in reshaping clinical practices within the Cath Lab.
Simplifying the Medis QFR® process, he highlighted its efficiency—requiring two orthogonal views of the angiogram. Through automated detection, the software generates a 3D dimensional model with a calibrated Medis QFR® value against Fractional Flow Reserve (FFR).

Dr. Toleva on Medis QFR® at TCT 2023 – Microvascular Dysfunction Assessment

Focusing on non-obstructive coronary arteries, the presentation of Dr. Olga Toleva at TCT 2023 highlights the challenges in microvascular dysfunction assessment and introduces promising advancements in non-wire-based techniques.

Medis QFR® is commercially available in 40+ countries

Our partners

Medis have built a robust partnership with our distributors to meet your needs. Our enduring collaboration with our partners gives us the flexibility to support you wherever you are.

Request a demo of Medis QFR®

You are only a click away from having your demo with an experienced Medis QFR® product specialist.

Frequently Asked Questions about QFR®

How can I best incorporate Medis QFR® into my practice?
Medis QFR® is very easy and seamless to adopt/incorporate into your current clinical practice for your physiology needs. The Medis QFR® software can be installed on a regular PC or a laptop of your choice. Medis QFR® has the capability to receive DICOM images from your enterprise cath lab system and PACS. This will help you perform both prospective and retrospective analysis of QFR from patient angiograms. The QFR analysis software can be made available on the large screen monitor in the Cath lab, to make measurements by the physician in real time and in the sterile environment. The software can also be used in the control room by the technicians and nursing staff and the results reviewed in the end by the physician.
What makes QFR® simple?

Medis QFR® is an angiography image-derived physiology measure. QFR simplifies the process of measuring physiology without the need of invasive wires, which are needed for metrics like FFR and iFR. The wire-based measures can consume between 15-30 minutes per measurement during the procedure. QFR® helps simplify the cost of the physiology procedure by eliminating the consumables, pressure wire and hyperemic pharmaceuticals like Adenosine.

How quickly will I get the analysis?

The QFR® analysis per target vessel segment is completed in less than 60 seconds.

What makes QFR® simple to use?

Quantitative flow ratio (QFR®) is an innovative technique that allows for the calculation of FFR (Fractional Flow Reserve) using three-dimensional quantitative coronary angiography (3D QCA) constructed from two angiograms. Unlike traditional methods, QFR® does not rely on hyperaemic agents like adenosine, and there’s no necessity for a pressure wire. QFR® has a user-friendly interface and offers a straightforward, valuable, and non-invasive approach to assess the functional significance of coronary artery stenosis.

Reference

Xing Z. et al., Diagnostic Performance of QFR for the Evaluation of Intermediate Coronary Artery Stenosis Confirmed by Fractional Flow Reserve. Braz J Cardiovasc Surg (2019). 10.21470/1678-9741-2018-0234

How will my patients benefit?
The patient will benefit with the eliminated discomfort from hyperemic pharmaceuticals like Adenosine. Using QFR® also eliminates the risk of ruptured arteries which can due to use of invasive wires.

* This decision-making / treatment planning claim does not have FDA clearance and can therefore NOT be used in the USA

3D-QCA and QFR measurements can be applied to X-ray images of the 4 major equipment manufacturers (GE, Philips, Siemens, Toshiba), and other vendors.

References

1. EuroIntervention 2023;19:464-481. DOI: 10.4244/EIJ-D-23-00194

2. Milzi A. et al., Coronary microvascular dysfunction as assessed by angiography-derived index of microvascular resistance co-localizes with and may explain the presence of ischemia in stress-cardiac magnetic resonance imaging in the absence of coronary artery disease. Cardiovasc. Med., 24 November 2022. Sec. Coronary Artery Disease. Volume 9 – 2022| https://doi.org/10.3389/fcvm.2022.1060764

3. Dettori R. et al., Quantitative Flow Ratio Is Associated with Extent and Severity of Ischemia in Non-Culprit Lesions of Patients with Myocardial Infarction. J Clin Med. 2021 Oct; 10(19): 4535. Published online 2021 Sep 30. doi: 10.3390/jcm10194535

4. Ullrich H. et al., Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO. Front. Cardiovasc. Med., 04 April 2022. Sec. Coronary Artery Disease. Volume 9 – 2022 |https://doi.org/10.3389/fcvm.2022.815434

5. Rigatelli et al: Modern atlas of invasive coronary angiography views: a practical approach for fellows and young interventionalists. Int J Cardiovasc Img 2022; doi.org/10.1007/s10554-021-02489-5    

6. Biscaglia, S., Tebaldi, M., Brugaletta, S., Cerrato, E., Erriquez, A., Passarini, G., Ielasi, A., Spitaleri, G., Di Girolamo, D., Mezzapelle, G., Geraci, S., Manfrini, M., Pavasini, R., Barbato, E., & Campo, G. (2019). Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC. Cardiovascular interventions12(20), 2079–2088. https://doi.org/10.1016/j.jcin.2019.06.003

7. Song L. et al., 2-Year Outcomes of Angiographic Quantitative Flow Ratio-Guided Coronary Interventions. J Am Coll Cardiol. 2022 Nov, 80 (22) 2089–2101

8. Westra J. 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. DOI: 10.1161/JAHA.118.009603

Regulatory Status

Medis QFR® has market clearance for Argentina, Australia, Brazil, Canada, Chile, all European Member States (CE), Indonesia, Japan (PMDA), Malaysia, Saudi Arabia, Singapore, South-Africa, South Korea, Turkey, United Kingdom and United States (510(K)).