Medis Receives CE Certification for Its Image-based Assessment of QFR® for Physiological Assessment of Coronary Obstructions without the Use of Pressure Wire

Medis received on this April 6, 2017 the CE mark for QFR, a novel method for evaluation coronary stenosis severity during coronary angiography. QFR is based on angiographic images and direct coronary flow estimation and allows for fast in-procedure results. This software solution is X-ray vendor independent and can be used on both biplane and monoplane X-ray systems. Image selection is facilitated through an angiographic acquisition guide and the total analysis time is typically around 4 minutes including image frame selection. Results have been validated against pressure-wire FFR values.

“This product QAngio XA 3D is the first product of its kind for image-based assessment of the coronary physiology in the cath lab that has received CE certification” said Hans Reiber, PhD, President and CEO of Medis medical imaging systems. “We are extremely proud that we have achieved this milestone together with our research and clinical partners. This approach provides a cost-effective solution in today’s cost-constrained healthcare sectors in the world, as we do not need a pressure wire and no adenosine”.

Clinical studies evaluating QFR have been carried out under the supervision of Niels R. Holm, MD, PhD of Aarhus University Hospital in Denmark. ”The need for costly pressure wires has been a major limitation in adoption of functional stenosis evaluation. As QFR does not require interrogation by pressure wires, it may make functional assessment available to patients on a much wider scale. The clinical evaluation showed that QFR improves diagnostic accuracy as compared to standard angiographic measurements and importantly we found that QFR is feasible during regular clinical procedures which has been a key focus throughout development”, said Niels Holm.

Prof. William Wijns, MD, PhD, now at CURAM and the Saolta University Healthcare Group, National University of Ireland, Galway, has supported our developments from the early beginning and has been senior author of the various publications. “I think this is a major and practical development in this innovative era of interventional cardiology. QFR can be used ubiquitously, pre-, during- and after an intervention, as well as on diagnostic image runs. This technology will support the worldwide usage of a physiological yardstick in the cath lab and across the spectrum of clinical work-up of patients with suspected or known coronary artery disease.” said Prof. Wijns.

About Medis. Medis is a Dutch medical technology company that has concentrated its activities on the development, validation, commercialization and support of analytical software solutions in the cardiovascular domain, covering X-ray, IVUS, OCT, MRI as well as MSCT applications. It exists now 27 years after it spun off from the Leiden University Medical Center (LUMC) in the Netherlands. Its headquarters is in Leiden and it has a subsidiary in Raleigh, USA and branch offices in Tokyo, Japan and Birmingham, UK. It has strategic collaborations with the LUMC, Shanghai Jiao Tong University and Pulse Medical Imaging Technology Co., Ltd. in Shanghai, China.