HeartFlow wins Japanese approval for FFRct tech

HeartFlow said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its HeartFlow FFRct technology, which uses algorithms to generate 3D models of blood flows and can help diagnose heart disease.

Redwood City, Calif.-based HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

“The MHLW’s approval of the HeartFlow FFRct Analysis is another important milestone for HeartFlow and will give physicians in Japan a new tool to determine the optimal treatment for patients with cardiovascular disease. With our commercial release in Japan, we expand our ability to help more clinicians diagnose cardiovascular disease non-invasively while reducing unnecessary invasive catheterizations and saving costs,” chair & CEO Dr. John Stevens said in a press release.

“We are very pleased that the MHLW has approved the novel HeartFlow FFRct Analysis. Having used the technology as part of clinical studies at our facility, we believe it has the potential to profoundly impact the way we care for cardiovascular patients in Japan,” Dr. Takashi Akasaka of Wakayama Medical University said in prepared remarks.

In August, the U.K.’s National Institute for Health and Care Excellence released guidance supporting the company’s HeartFlow FFRct tech.

The organization’s medical technology advisory committee released provisional recommendations that support using the FFRct tech in patients with stable recent chest pain which is through to be heart related and have an intermediate risk of heart disease, according to a report from NICE.

The group said that, due to the number of more invasive and complicated investigations that could be avoided with the test, that the system could save the U.K.’s NHS more than $262 (U.K. £200) per patient.

In June, HeartFlow said it launched a new version of its FFRct cardiac imaging platform. The new iteration improves the FFRct algorithms and streamlines case processing, incorporates Amazon Web Services for its cloud-based infrastructure and upgrades the software’s security, the company said.

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