CathWorks Gains EU MDR Approval for FFRangio System

May 17, 2024—CathWorks announced that the company’s FFRangio system is now approved under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The EU MDR, which replaces the previous Medical Device Directive 93/42/EEC, places greater emphasis on safety measures, risk management, postmarket surveillance, and data collection of medical devices for companies seeking European market access.

According to the company, the CathWorks FFRangio system combines artificial intelligence and computational science for the diagnosis and treatment of cardiovascular disease. The technology obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires.

CathWorks also announced that the FFRangio technology was featured at the annual EuroPCR conference, held May 14-17 in Paris, France. At EuroPCR, several scientific sessions focused on the FFRangio system demonstrated its role in the diagnosis and treatment of patients with coronary artery disease.

The abstract “FFRangio-Based PCI Were Associated With Better 1-Year Clinical Outcomes in an International Registry” was presented during a late-breaking trials and hotline session by Yuetsu Kikuta, MD, with Fukuyama Cardiovascular Hospital in Fukuyama, Japan. Additionally, “Comparison Between FFRangio Sizing Tool and IVUS Imaging Measurements for PCI” was presented by Kazuhiro Dan, MD, with Ichinomiya Nishi Hospital in Ichinomiya, Japan.

As part of CathWorks’ strategic partnership with Medtronic, the companies cosponsored a symposium that discussed how FFRangio can be adopted in everyday practice and aid in clinical decision-making for patients with coronary artery disease. The symposium, “CathWorks FFRangio—Enhancing patient care,” was led by Rasha Al-Lamee, MBBS, with Imperial College London in London, United Kingdom, and Ajay Kirtane, MD, with Columbia University Irving Medical Center in New York, New York. The latest generation of the FFRangio application was showcased in the Medtronic booth at EuroPCR, noted CathWorks.