Approval by the Japanese Ministry of Health, Labour and Welfare for the application to provide reimbursement for the CathWorks FFRangio system for fractional flow reserve assessment has been provided, announced CathWorks. This approval is greatly beneficial in making the system much more accessible for making decisions for coronary artery disease in Japan.
The FFRangio system, which is also commercially available in Europe and the United States of America, had received approval in December 2019 from the Japanese Pharmaceuticals and Medical Devices Agency.
The FFRangio system is a noninvasive technique that can be used during coronary angiography at no additional costs or added clinical risks, as claimed by CathWorks. In addition, clinical trials as carried out by the company show that the FFRangio system has high levels of accuracy compared to the traditional FFR method that was wire-based.
Hiroyoshi Yokoi, MD, Vice Chairman of the Japanese Association of Cardiovascular Intervention and Therapeutics and President of Fukuoka Sanno Hospital, Fukuoka, Japan, announced that the FFRangio system is greatly beneficial to patients and doctors since it helps in determining the physiological effects of coronary artery disease without the need for any hyperemic agents or traditional pressure wires. Furthermore, this system has become more accessible to doctors and patients with the approval for reimbursement.
Hitoshi Matsuo, MD, President of Gifu Heart Center, Gifu, Japan, said that it is important to act in a cost-effective but fast way to plan the appropriate treatment path in patients that present with suspected coronary artery disease. FFRangio has been able to combine machine-learning, artificial intelligence, and a smooth user experience to help in the management and treatment of patients as seen in their facility.