Medlytic Labs

medLYTIC Labs aim to revolutionize medical decision making during invasive treatment of coronary artery disease (CAD) with the application of ultra-fast numerical computer models. Atherosclerosis produces stenoses in the coronary arteries that impede blood flow and oxygen delivery to the myocardium, resulting in ischemic coronary artery disease. Coronary angiography allows for evaluation of the anatomical characteristics of vascular stenoses but is often inaccurate in identifying truly functionally significant coronary artery stenoses. The physiological significance of a stenosis is best judged in association to given flow conditions. In fact, mean pressure drop across an arterial stenosis increases nonlinearly with percent area stenosis and with increasing flow rates. Fractional Flow Reserve (FFR) is a hemodynamic index that quantifies the functional severity of a coronary artery stenosis. In consequence, current guidelines recommend the use of FFR in identifying functionally significant epicardial coronary artery stenoses and determining the need for percutaneous coronary interventions (PCI) with balloons and stents.

Established methods for FFR measurement mandate the invasive use of a guidewire along with the administration of pharmacological vasodilators that produce patient discomfort. Image-based computer methods have emerged for computer simulation of FFR, but they routinely rely on a three-dimensional reconstruction of the coronary arterial tree, they cannot reliably simulate hyperemia and they are uniformly time-consuming in the order of several minutes or even hours per image-reconstruction and FFR calculation. All the latter are major drawbacks restricting the clinical applicability and patient throughput in modern catheterization laboratories.

medLYTIC Labs have developed ultra-fast sophisticated mathematical computer models that analyze routine 2-dimensional instead of 3-dimensional angiographic images and can calculate reliably FFR within a few seconds (FFR2D). Our software performs not only a quick, but also completely non-invasive and wire-free calculation of Fractional Flow Reserve (FFR). We transform routine angiograms into objective vessel physiology, along with anatomic insights, providing all the information needed to help with medical decision making during percutaneous coronary intervention (PCI) treatment decisions. Wire-based FFR has matured to a multi-billion dollar market with several established major clinical benefits such as significantly lower long-term risk of death, lower risk of myocardial infarction, and lower risk of repeat coronary revascularization compared to a stand-alone angiography-guided PCI strategy. The proposed medical software aims to expedite physiological coronary lesion assessment and eventually replace wire-based FFR measurement.

medLYTIC Labs’ invention performs numerical flow analysis of 2-dimensional angiographic images to calculate hyperemic pressure drops across arterial stenoses. The software derives an array of hemodynamic indices (including FFR and IMR) claiming several added value propositions such as:

(1) image-based wire-free analysis that avoids the need for invasive application of intravascular pressure wires or other catheters, 
(2) no need for pharmacological induction of hyperemia (vasodilator) of the coronary or other vessels, 
(3) application in standard two-dimensional X-Ray angiographic images, but also multiplanar angiographic images derived from other modalities like magnetic resonance, or computed tomography angiography, 
(4) ultra-fast computation process in the order of a few seconds compared to several minutes or even hours in case of competing technologies, and 
(5) complete obviation of cumbersome, laborious and time-consuming 3-dimensional image reconstruction of vascular geometries,
(6) holistic approach in assessment of cardiac physiology high probability of correct classification of critical epicardial stenoses and high precision measurements compared to other angio-based technologies or pressure-wire measurements themselves,
(7) the pipeline allows for further determination of several physiological metrics like absolute coronary flow at rest and hyperemia, basal and hyperemic stenosis resistance, as well as basal and hyperemic microvascular resistance, and the index of microvascular resistance (IMR).
(8) The FFR2D pipeline applies also directly on cardiac CTA datasets for FFR-CT computations with improved ease and speed by downgrading complexity from the 3D framework to a 2D multiplanar imaging approach.