HeartFlow Receives National Reimbursement Approval in Japan
HeartFlow Analysis to be covered by Japan’s health insurance system, making it more broadly
available to patients with suspected coronary artery disease
REDWOOD CITY, Calif. - November 14, 2018 -
today announced that the
Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the recommendation by
the Central Social Insurance Medical Council (Chuikyo) to provide reimbursement for the
HeartFlow FFRct Analysis. The HeartFlow Analysis has already received regulatory approval
from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Reimbursement will
go into effect beginning December 1, 2018, enabling greater access for patients with suspected
coronary artery disease (CAD).
“When a patient presents with symptoms suggesting CAD, we want to be able to quickly and
effectively diagnose patients while reducing the need for unnecessary tests or invasive
procedures,” said Takashi Akasaka, M.D., Ph.D., Professor of Medicine, Department of
Cardiovascular Medicine, Wakayama Medical University. “In clinical studies, we were able to
see firsthand how the HeartFlow Analysis can help to improve patient management and avoid
invasive procedures in some patients. The reimbursement approval will enable more physicians
and patients to obtain benefits from this ground-breaking technology.”
“Adding the HeartFlow Analysis to the anatomical information provided by a coronary CT
angiogram enables us to better detect and treat CAD,” said Hiroyoshi Yokoi, M.D., Director,
Cardiovascular Center, Fukuoka Sanno Hospital and Vice Chairman, Japan Association of
Cardiovascular Intervention and Therapeutics. “With the broader availability of the HeartFlow
Analysis, physicians in Japan will be able to more efficiently diagnose CAD while minimizing
unnecessary tests or delaying care for patients.”
CAD is the world’s leading cause of death, and is responsible for approximately half of all heart-
disease related deaths in Japan. Clinicians diagnosing someone with suspected CAD want to
know as definitively as possible if the individual has a significant blockage in their coronary
arteries. They also want to know the impact of that blockage on blood flow so they can
determine which treatment pathway is most appropriate (e.g., medical management, stenting or
coronary artery bypass grafting).
The HeartFlow Analysis is a non-invasive, personalized cardiac test that applies artificial
intelligence to image data taken from a standard coronary computed tomography (CT) scan to
create a digital 3D model of the patient’s arteries. It then applies advanced algorithms to solve
millions of complex equations to assess the impact any blockages have on blood flow to the
heart. The HeartFlow Analysis is provided via a secure online interface to offer actionable
information to enable clinicians to determine the optimal course of treatment.
The HeartFlow technology has been demonstrated to reduce unnecessary and invasive
diagnostic coronary angiography procedures, which can be associated with bleeding, stroke,
major blood vessel damage and other serious complications. It also significantly reduces
healthcare costs for hospitals.
“The reimbursement approval in Japan is an important milestone for HeartFlow as we work to
make our state-of-the-art technology available to more patients around the world,” said John H.
Stevens, M.D., president and chief executive officer, HeartFlow. “Our commercial launch will
begin immediately and we look forward to giving clinicians in Japan a new tool to help them
confidently diagnosis CAD and determine the optimal treatment path for patients.”
To date, clinicians around the world have used the HeartFlow Analysis for more than 25,000
patients to aid in the diagnosis of heart disease.
About HeartFlow, Inc.
HeartFlow, Inc. is a medical technology company redefining the way heart disease is diagnosed
and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a
personalized 3D model of the heart. By using this model, clinicians can better evaluate the
impact a blockage has on blood flow and determine the best treatment for patients. Our
technology is reflective of our Silicon Valley roots and incorporates decades of scientific
evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is
commercially available in the United States, Canada, Europe and Japan. For more information,
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Douglas PS, DeBruyne B, Pontone G., Patel MR, et al. One-year outcomes of FFRCT-guided care in patients with
suspected coronary disease: The PLATFORM Study.
J Am Coll Cardiol