Heartflow has received US Food and Drug Administration (FDA) 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm and the platform is now available.
The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualisation of plaque type, volume, and distribution.
Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of its lines of business, including Commercial and Medicare Advantage plans, beginning in October.
Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with a reported 95% agreement with the gold standard, intravascular ultrasound (IVUS), using blinded core lab adjudication, Heartflow says in a press release. The latest algorithm advancement shows 21% improvement in plaque detection compared to the first-generation algorithm, so clinicians can be confident in their diagnosis and management of coronary artery disease.
“Understanding not only how much plaque is present, but also plaque type and distribution, is critical in predicting patient risk and guiding personalised treatment,” said Matthew Budoff (David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical Center, Los Angeles, USA). “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.”
Cigna is the second US national insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, following a similar decision by UnitedHealthcare. The updated coverage will become effective on October 1 for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1–69% stenosis) identified on coronary computed tomography angiography (CTA).
“Heartflow is proud to lead the way in coronary plaque analysis with our next-gen platform, delivering the most representative visualisation and context available for assessing patients’ disease and risk. Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology to positively impact care for its members across the USA,” said John Farquhar, president and chief executive officer of Heartflow. “Heartflow analyses give clinicians a view of coronary plaque by type and impact on blood flow with FFRCT that’s key to informing management strategies. These latest advancements build on Heartflow’s record of proven innovation, leveraging clinical rigour and the world’s largest dataset of coronary CTA images to continually improve our technology for clinicians and patients.”
Heartflow recently shared insights from the DECIDE registry, showing Heartflow Plaque Analysis led to medical management change in over 50% of patients beyond coronary CTA alone, resulting in an expected ~15% event reduction.
