1st choice for Cardiovascular Imaging Software Solutions

Medis QANGIO XA 3D RECEIVES 510K CLEARANCE


Leiden, The Netherlands – June 3, 2019


Medis Medical Imaging Systems B.V. is pleased to announce that it has received clearance from the U.S. Food and Drug Administration for its QANGIO XA 3D technology (QFR®), a non-invasive imaging technique for the assessment of the functional significance of coronary lesions without the need for a pressure wire, nor adenosine.

“This approval allows us now to provide the Medis‘ QFR® solution to Health Care providers in the United States, to enable a more efficient and cost effective way to diagnose and treat patients with suspected or known coronary artery disease,” said Hans Brons, CEO at Medis.

Coronary Artery Diseases (CAD) develops when the coronary arteries narrow, reducing blood flow to the heart, resulting in angina (chest pain), myocardial infarction (heart attack) or death. When diagnosing suspected CAD, there is no room for doubt.

“Image-based QFR can quickly and efficiently help clinicians non-invasively determine whether or not they need to perform angioplasty or stenting in 5 minutes or less,” said Prof. Hans Reiber, PhD., CSO at Medis. “This is significantly quicker than traditional wire-based FFR procedures that can take 10-15 minutes, are invasive and require the use of a hyperemic drug, making the procedure very demanding on a patient.”

QFR is based on standard X-ray angiographic images and direct coronary flow estimation and allows for fast inprocedure results. This software solution is designed to be X-ray vendor independent and to be used on both biplane and monoplane X-ray angiographic imaging systems. Image selection is facilitated through an angiographic acquisition guide and the total analysis time is typically 4-5 minutes including image frame selection.

By using QANGIO XA 3D, clinicians can significantly reduce stent overuse and associated risks, better determine the correct stent length and landing zones, and help establish optimal viewing angles for stent positioning. The results are better for the patient and the clinician.

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 30 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, with Shanghai Jiao Tong University and Pulse Medical Imaging Technology Co., Ltd. in Shanghai, China. For those who want to follow the worldwide acceptance and applications, please, sign up to the QFR Newsletter here >>

For more information about QFR® please click here >>