HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis.
The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1.
“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. 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,” Dr. Takashi Akasaka of Wakayama Medical University said in a prepared statement.
The HeartFlow analysis is a non-invasive, personalized cardiac test that applies artificial intelligence to image data taken from standard coronary computed tomography scans to produce a digital 3D model of a patient’s arteries. The system then applies algorithms to assess the impact of blockages on blood flow to the heart, the company said.
“Adding the HeartFlow Analysis to the anatomical information provided by a coronary CT angiogram enables us to better detect and treat CAD. 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,” Dr. Hiroyoshi Yokoi of the Fukuoka Sanno Hospital said in a prepared release.
The company touted that its technology has been shown to reduce unnecessary and invasive diagnostic coronary angiography procedures which are raise costs and are associated with bleeding, stroke, major blood vessel damage and other serious complications.
“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. Our commercial launch will begin immediately and we look forward to giving clinicians in Japan a new tool to help them confidently diagnose CAD and determine the optimal treatment path for patients,” prez & CEO Dr. John Stevens said in a press release.
In August, HeartFlow released data from two studies of its HeartFlow fractional flow reserve FFRct analysis system, touting that the system allows for the more effective differentiation of patients who need coronary stenting or bypass surgery and those who can be managed on medications alone.
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