Data supports portfolio of HeartFlow coronary care solutions

July 28, 2023 By Sean Whooley

HeartFlow today announced positive results from clinical studies evaluating its portfolio of coronary care technologies.

Mountain View, California-based HeartFlow said the studies demonstrate the accuracy, utility and efficiency of its portfolio. The RevealPlaque, Decode and Smart-CT studies looked at the company’s coronary computed tomography angiography (CCTA)-based systems.

HeartFlow presented results at the Society of Cardiovascular Computed Tomography (SCCT) Conference in Boston.

The company’s RoadMap Analysis non-invasively helps to identify stenoses in the coronary arteries. Its FFRCT Analysis assesses coronary blood flow and the Plaque Analysis characterizes and quantifies coronary atherosclerosis. Together, the comprehensive solution offers data not currently available with traditional non-invasive diagnostic tools. HeartFlow says this allows clinicians to see the full picture of the patients’ coronary artery disease (CAD).

The AI-powered Plaque Analysis and Roadmap Analysis products received FDA clearance in October 2022. Commercial availability spans the U.S., UK, Canada, Europe and Japan. HeartFlow boosted its commercial efforts by raising $215 million earlier this year.

“Until now, clinicians have not had access to a complete view of a patient’s heart health with accurate data on coronary anatomy, physiology, and plaque. We are thrilled to now offer HeartFlow’s comprehensive solution, supported and validated by the findings of these studies,” said John Farquhar, CEO of HeartFlow. “Our company remains committed to empowering providers to make the best clinical decisions by strengthening precision CAD management solutions with the CCTA pathway.”

RevealPlaque, a large, global, prospective study evaluated the accuracy of the AI-based Plaque Analysis against intravascular ultrasound (IVUS). HeartFlow Plaque Analysis demonstrated a 95% agreement with IVUS — the current gold standard — in quantification and characterization of total plaque volume.

Decode evaluated changes in treatment management decisions by clinicians using Plaque Analysis alongside CCTA. It compared this to decisions made with CCTA alone. Clinicians using the combination changed their management decisions for 66% of patients compared to using CCTA alone. Nearly 50% of patients with a calcium score of zero received reclassification following Plaque Analysis review. HeartFlow says this highlighted the importance of quantifying total plaque beyond just calcium.

Smart-CT measured the difference in CCTA read time using RoadMap analysis compared to without. Using RoadMap Analysis, clinicians read cases 25% faster while maintaining diagnostic accuracy, gaining efficiency. The study also showed that RoadMap Analysis elevated consistency in CAD diagnosis and amplified confidence in CCTA reads by more than 24%.

HeartFlow said the study results, plus the launch of its all-in-one HeartFlow ONE portfolio, mark a “significant milestone” in its mission.

Filed Under: Cardiovascular, Clinical Trials, Diagnostics, Digital Health, Health Technology, Software / IT Tagged With: HeartFlow