CathWorks has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application 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 USA 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 hyperaemic agents, which provides significant benefits to clinicians and patients,” said Hiroyoshi Yokoi, president of Fukuoka Sanno Hospital, Fukuoka, Japan 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, president of Gifu Heart Center, Gifu, Japan. “Our facility has been able to experience first-hand how FFRangio combines artificial intelligence, machine learning, and a streamlined user experience to improve the way we manage and treat our patients.”
The FFRangio System is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. Clinical trials have demonstrated the FFRangio system is highly accurate compared to traditional wire based fractional flow reserve (FFR) methods.
“The reimbursement approval in Japan is a significant and important milestone for CathWorks,” said Ramin Mousavi, CEO of CathWorks. “We are pleased with the early adoption of FFRangio in Japan, and grateful for the tremendous physician support of the technology. We look forward to expanding our commercial presence to make FFRangio and non-invasive CAD decision-making available to more clinicians and patients in Japan and around the world.”