HeartFlow's FFRct Technology for CAD Receives Positive Review on Blue Cross Blue Shield's Evidence Street

June 12, 2017—HeartFlow, Inc. announced that the Blue Cross Blue Shield (BCBS) Association’s Evidence Street has issued a positive health care evidence review of the company’s HeartFlow FFRct. Evidence Street was launched in December 2016 as a web-based platform to provide health care decision makers with easy access to impartial medical evidence reviews for devices, diagnostics, and pharmaceuticals.

Using noninvasive fractional flow reserve (FFR) computed tomography (CT), the technology provides insight into both the extent of coronary artery disease (CAD) and the affect the disease has on blood flow to the heart. Combining anatomic information from a coronary CT angiogram and physiology from the HeartFlow FFRct, clinicians can select an appropriate and personalized treatment for each patient.

According to HeartFlow, the Evidence Street review assessed the technical performance, diagnostic accuracy, and clinical utility of HeartFlow FFRct and determined that it provides a meaningful improvement in net health outcome when used to guide the care of patients with stable chest pain who are at intermediate risk of CAD and are being considered for invasive coronary angiography.

Evidence Street’s assessment of HeartFlow FFRct is summarized in a 19-page report, which concludes that coronary CT angiography with a selective FFRct strategy would likely lead to changes in management that would be expected to improve health outcomes by further limiting unnecessary invasive coronary angiography testing.

HeartFlow stated that BCBS’s Evidence Street is one of the most rigorous health technology assessments with significant global reach and influence. Evidence Street provides health care technology evaluations for the BCBS Association, a national federation of 36 independent, community based, and locally operated BCBS companies that collectively provide health care coverage for 105 million Americans.

In addition to Evidence Street, HeartFlow FFRct has received a positive coverage decision from Aetna, covering more than 46 million people, and recommendation from the National Institute for Health and Care Excellence of the United Kingdom's National Health Service, which covers 59 million people, and issued positive guidance, recommending the technology to help determine the cause of stable chest pain in patients. The National Institute for Health and Care Excellence concluded that HeartFlow FFRct is safe, has a high level of diagnostic accuracy, may avoid the need for invasive coronary angiography, which is associated with risks, and is cost-effective.

HeartFlow FFRct has received regulatory approval and is commercially available in the United States, Canada, Europe. and Japan.