HeartFlow FFRCT Analysis

Built on Clinical Data

Our HeartFlow Analysis is a fundamentally different approach to assessing patients with suspected coronary artery disease. We aim to provide a superior alternative to other testing methods including standard stress testing, such as SPECT and stress echo, that improves outcomes and the patient experience. In validating our approach, we’ve invested decades of scientific research and development, conducted multiple clinical studies, and tested performance in real world settings. This long history of development, including more than 500 peer-reviewed publications, has directly led to growing recognition of the HeartFlow Analysis as an important part of a value-based healthcare system.

The Evidence

Results from studies evaluating more than 10,000 patients demonstrate the impact of the HeartFlow Analysis. The NXT study, which was the basis of our FDA clearance, showed an accuracy of 86% compared to the gold standard of invasive FFR, with high sensitivity and specificity1. The PLATFORM study demonstrated an improved patient experience and reduction of costs, without compromising on clinical outcomes2. PLATFORM results show that, compared to usual care, a pathway of coronary CT and the HeartFlow Analysis resulted in2:

Recognition and Reimbursement

The healthcare community recognizes the potential of the HeartFlow Analysis and the strength of our clinical data. While transitioning to new technologies is never easy, the barriers to adopting HeartFlow are falling. Now, millions of patients will have access to the technology. Here are some of the recent changes:

$950 reimbursement for Medicare patients
due to the Centers for Medicare & Medicaid Services (CMS) creating a New Technology Ambulatory Payment Classification (APC) for the HeartFlow Analysis

96% of the US population
now has access to the HeartFlow Analysis through private commercial payers and Medicare

UK reimbursement from the National Health Service (NHS)
as part of their Innovation and Technology Payment program, following a medical technology guidance issued by NICE recommending the HeartFlow Analysis as the most cost-effective option following a coronary CT

1 Nørgaard BL, et al. Diagnostic performance of non-invasive fractional flow reserve derived from coronary CT angiography in suspected coronary artery disease: The NXT Trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol2014;63(12):1145-55.

2 Douglas, et al. Eur Heart J. 2015.

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