Cardio Flow Design’s iTFlow Software Approved by FDA for Blood Flow Analysis

June 19, 2023—Cardio Flow Design Inc. announced FDA approval of the company’s iTFlow software solution for blood flow analysis through four-dimensional flow MRI data. iTFlow supports blood flow analysis and evaluation in the fields of cardiovascular surgery and radiology.

According to the company, the FDA approval of iTFlow will enable health care professionals to make more precise and effective decisions in patient care. The software has the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions.

Based on MRI data, users can perform their own analysis and visualization of blood flow. It enables the visualization of fluid dynamics in the heart and blood vessels in both two and three dimensions, even without the use of contrast agents.

Additionally, various quantitative evaluations can be made, including flow rate, velocity, pathline, streamline, and other parameters. Combining advanced algorithms and image analysis techniques assists physicians and health care professionals in diagnosis and treatment planning, noted the company.

The iTFlow software was invented by Keiichi Itatani, MD, a cardiovascular surgeon specializing in adult congenital heart disease.

“We developed this software with the aim of enabling all physicians, regardless of their level of experience, to propose the most appropriate treatment for patients even with complicated anatomy and cardiac function by quantitatively evaluating blood flow,” stated Dr. Itatani in the company’s press release.

Yue-Hin Loke, MD, Associate Professor of Pediatrics at Children’s National Hospital in Washington, DC, conducted retrospective blood flow analysis research with iTFlow prior to FDA approval.

Dr. Loke commented in the press release, “Cardiac magnetic imaging research has demonstrated the emerging potential of advanced intracardiac flow analysis in heart disease beyond traditional measurements. To that end, iTFlow provides a front-line software interface to measure kinetic energies, vortexes, and shear stresses inside the heart without the need for complex in-house engineering software. I am excited by the potential of software such as iTFlow in bringing intracardiac flow analysis to clinical cardiology.” The company advised that measurement of kinetic energy, vortexes, and wall shear stress is currently for research use only.