A NOvel FFR Measurement fOR accurate dEtermination of stenosis Functional severity in ischemic hEARt disease

ended

Medis medical imaging systems BV (MEDIS), with 25 years of experience in medical imaging, will introduce a novel imaging-based biomarker as an accurate proxy for functional stenosis severity, creating a breakthrough in the treatment of ischemic heart disease (IHD). This non-invasive imaging algorithm should replace the current standard of using a vascular pressure wire to measure the Fractional Flow Reserve (FFR) - a measure for the physiologic significance of a coronary obstruction on the basis of which the interventional cardiologist decides whether an obstruction needs to be treated with stent placement, or otherwise should be left untreated. Using pressure-wire FFR is risky, time consuming, costly, associated with additional X-ray radiation, not always accurate and not applicable in highly curved arteries. MEDIS has developed a functional prototype of its imaging algorithm (FFRQCA) that accurately calculates the FFR from readily available 2D X-ray images through 3D reconstruction, advanced image processing algorithms and computational fluid dynamics. In a direct comparison with the current standard, this novel approach showed excellent diagnostic accuracy of 88%. Efforts to further optimise the technology are currently ongoing: a multi-centre investigator-driven trial is being carried out across 2 European countries, the US and China. In this Stage 1 SME Instrument project, MEDIS will investigate the commercial feasibility of this innovation that has already sparked enthusiasm amongst interventional cardiologists worldwide.