CathWorks FFRangio System Receives National Reimbursement Approval in Japan

July 26, 2021—CathWorks announced that the Japanese Ministry of Health, Labor, and Welfare has approved the application to provide reimbursement for the CathWorks FFRangio system for fractional flow reserve (FFR) assessment. The approval makes the system more broadly available for coronary artery disease (CAD) decision-making in Japan.

The FFRangio system received regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency in December 2019. It is also commercially available in the United States and Europe.

According to CathWorks, the noninvasive FFRangio system is used intraprocedurally during coronary angiography without adding additional clinical risk or per-procedure costs. The company stated that clinical trials have demonstrated that the FFRangio system is highly accurate compared to traditional wire-based FFR methods.

“The FFRangio system enables us to quickly identify the physiologic significance of CAD without the need for traditional pressure wires or hyperemic agents, which provides significant benefits to clinicians and patients,” commented Hiroyoshi Yokoi, MD, in the company’s announcement. “The Japan reimbursement approval is an important step to enable more physicians and patients to have access to this innovative technology.” Dr. Yokoi serves as Vice Chairman of the Japanese Association of Cardiovascular Intervention and Therapeutics and President of Fukuoka Sanno Hospital in Fukuoka, Japan.

Hitoshi Matsuo, MD, President of Gifu Heart Center, in Gifu, Japan, added, “When patients present with suspected CAD, it is important that we can quickly and cost-effectively determine the appropriate treatment plan. Our facility has been able to experience firsthand how FFRangio combines artificial intelligence, machine learning, and a streamlined user experience to improve the way we manage and treat our patients.”