HeartFlow FFRct approved for use in Japan

HeartFlow FFRct
HeartFlow FFRct

HeartFlow has announced the approval of its HeartFlow FFRCT analysis by the Japanese Ministry of Health, Labour and Welfare. A press release reports that the analysis system is the only non-invasive technology designed to deliver insights on both the extent of a coronary blockage and any impact the blockage has on blood flow to the heart, aiding clinicians in selecting an appropriate treatment. 

The press release explains that HeartFlow FFRCT analysis is a web-based platform that aids clinicians in diagnosing coronary artery disease, and provides personalised, actionable information to physicians to manage each patient. It adds that the technology solves millions of complex equations simulating blood flow in the coronary arteries to provide mathematically computed fractional flow reserve (FFRCT) values. The result is a personalised colour-coded model of the patient’s coronary arteries that aids physicians in determining, vessel-by-vessel, if sufficient blood is reaching the heart.

Speaking about the Japanese approval, Takashi Akasaka (Department of Cardiovascular Medicine, Wakayama Medical University, Japan) comments: “We are very pleased that the Ministry of Health, Labour and Welfare 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.”

Commercially available in the USA, Europe and Canada, according to the press release, the technology has been proven to reduce the need for invasive and costly procedures to diagnose patients suspected of having coronary artery disease. It has the potential to positively impact a significant patient population in Japan, where heart disease is the second leading cause of death and coronary artery disease accounts for approximately half of these deaths.