FFRangio System is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs.
CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has agreed to provide reimbursement for the CathWorks FFRangio System, making it more broadly available for coronary artery disease decision-making in Japan. The CathWorks FFRangio System has already received regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in December 2019 and is also commercially available in the United States and Europe.
“The FFRangio System enables us to quickly identify the physiologic significance of coronary artery disease (CAD) without the need for traditional pressure wires or hyperemic agents, which provides significant benefits to clinicians and patients,” said Hiroyoshi Yokoi, M.D., president of Fukuoka Sanno Hospital and vice chairman, Japanese Association of Cardiovascular Intervention and Therapeutics. “The Japan reimbursement approval is an important step to enable more physicians and patients to have access to this innovative technology.”
“When patients present with suspected CAD, it is important that we can quickly and cost-effectively determine the appropriate treatment plan,” said Hitoshi Matsuo, M.D., president of Gifu Heart Center. “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.”