HeartFlow Receives Approval for FFR_CT Analysis Technology in Japan

November 17, 2016—HeartFlow, Inc. announced today that its HeartFlow FFR_CT Analysis technology has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). According to the company, the HeartFlow FFR_CT Analysis is a noninvasive technology that delivers insights on both the extent of coronary blockage and any impact the blockage has on blood flow to the heart, aiding clinicians in selecting an appropriate treatment.    

“We are very pleased that the MHLW has approved the novel HeartFlow FFR_CT Analysis,” commented Takashi Akasaka, MD, PhD, Professor of Medicine, Department of Cardiovascular Medicine, Wakayama Medical University, Japan. “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.”

The HeartFlow FFR_CT Analysis helps physicians diagnose coronary artery disease and better manage each patient with personalized, actionable information. The web-based technology simulates blood flow in the coronary arteries to provide mathematically computed fractional flow reserve (FFR_CT) values. The data output then shows a personalized, color-coded model of the patient’s coronary arteries that allows physicians to determine, vessel-by-vessel, if sufficient blood is reaching the heart.

This technology, which is already commercially available in the United States, Europe, and Canada, 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 those deaths.