FAVOR III Europe substudy confirms that Medis QFR® compares to the FFR standard
Leiden, The Netherlands – May 23, 2025 – Medis Medical Imaging today shares its view on the results of the REPEAT-QFR substudy of FAVOR III Europe, presented by Dr. Sophie K. Kristensen during EuroPCR 2025, which further reinforces the diagnostic strength of angiography-derived physiology when supported by proper on-site QFR analysis. The REPEAT-QFR substudy revealed a strong signal towards non-inferiority of Medis QFR® to invasive Fractional Flow Reserve (FFR).
Patients with clinically-acceptable onsite QFR analysis experienced Major Adverse Cardiac Events (MACE) rates comparable to those achieved with FFR1,2 – and without requiring pressure wires or hyperemic agents. When onsite QFR analyses were rated as acceptable, good, or very good by the corelab, hazard ratios for MACE dropped by more than half compared to poor-quality analyses. This correlation underscores that strong clinical results are achievable with Medis QFR® when imaging standards are met.
Notably, 90% of patients undergoing on-site QFR and included in the outcome analysis met these quality thresholds. This validates the technology’s diagnostic value in real-world use despite the use of an early version of the software, released 6 years ago. “Over the last 10 years, since we invented QFR, we have rapidly innovated and updated the software based on wide clinical input,” said Dr. Maya Barley, CEO of Medis Medical Imaging. “The newest generation, Medis QFR 3.0, now commercially available, builds directly on what we’ve learned from multiple international trials — significantly reducing operator dependence, accelerating the workflow, and increasing the robustness of every analysis.”
“As an investigator in the FAVOR III Europe trial, I find these results very encouraging,” said dr. Julien Adjedj, Institute Saint Laurent du Var. “They show that QFR is not only feasible, but effective in the majority of patients we see in daily practice if we pay attention to image quality fundamentals.”
Unlike traditional wire-based FFR, which delivers a single-point pressure measurement, Medis QFR® provides a comprehensive, vessel-level view of coronary physiology. By integrating anatomical insights from 3D angiography with advanced flow dynamics, Medis QFR® enables clinicians to assess the functional significance of disease along the entire coronary vessel—not just at a single site. This broader perspective supports more informed treatment planning, revealing both the anatomical structure and physiological burden of disease in a single workflow without the need of a pressure wire.
“More than ever, it’s clear that modern physiology starts with Medis QFR,” added Hans Reiber, Chief Scientific Officer at Medis. “We’ve eliminated unnecessary steps, reduced sources of operator variability, and built a platform that mirrors core-lab standards in the hands of every operator, and widely available in the cardiology department based on the new web-based platform .”
Medis QFR® has now been featured in multiple international trials—including FAVOR II Europe and FAVOR II Japan, FAVOR III China and FAVOR III Europe, the Multi-Talent SMT-trial, etc—and was awarded a Class I recommendation in three categories of the 2024 ESC Guidelines for Chronic Coronary Syndrome. Medis QFR® 3.0 is FDA and CE-cleared and available across the U.S., Europe, and other global markets.
For more details or to schedule a demonstration of the new generation Medis QFR® contact us via sales@medisimaging.com.
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About Medis Medical Imaging
For over 35 years, Medis has provided innovative and clinically validated software solutions to the cardiovascular imaging community. Medis’ tools are trusted globally by clinicians, researchers, and industry partners to improve diagnostic precision and patient care. With a strong commitment to quality and usability, Medis continues to lead in the advancement of non-invasive cardiovascular imaging.
Media Contact:
Arnoud van Dorth – avandorth@medisimaging.com
medisimaging.com
References
1. Davies JE, et al; Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18. PMID: 28317458.
2. Götberg M, et al; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18. PMID: 28317438.
