CathWorks Fourth-Generation FFRangio System Approved in Japan

October 6, 2022—CathWorks announced the approval of the fourth-generation CathWorks FFRangio system by Japan’s Pharmaceuticals and Medical Devices Agency.

The Israel-based company’s noninvasive fractional flow reserve (FFR) diagnostic technology is intended for the diagnosis and treatment of coronary artery disease (CAD). It is also commercially available in the United States and Europe. In Japan, it is approved for the diagnosis of functional ischemia for patients with ischemic CAD.

The company noted that the fourth-generation application includes significant automation and enhancements while providing the same 93% diagnostic accuracy when compared to invasive wire-derived FFR.

“The FFRangio system enables us to quickly perform a comprehensive physiologic assessment of CAD without the need for invasive pressure wires or hyperemic agents, providing significant benefits to clinicians and patients,” commented Yutaka Hikichi, MD, in the company’s press release. “The approval of the fourth-generation application offers significant automation and enhancements, further simplifying the utilization of the platform.” Dr. Hikichi is Director of the Heart Center at Saga-Ken Medical Center Koseikan in Saga, Japan.

Mamoru Nanasato, MD, added, “CAD is a life-threatening disease, and it is critical that we can quickly, effectively, and cost-effectively diagnose the disease and determine the appropriate treatment plan. We have been able to experience firsthand how FFRangio can transform the diagnosis and treatment of our patients with CAD.” Dr. Nanasato is Chief Director of the Department of Cardiology at Sakakibara Heart Institute in Tokyo, Japan.

In July 2022, a strategic partnership was announced between CathWorks and Medtronic. As part of the agreement, Medtronic will invest up to $75 million and immediately begin copromotion of the CathWorks FFRangio system in the United States, Europe, and Japan.