Revolutionizing Coronary Artery Disease Diagnosis: The Rise of HeartFlow

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Coronary Artery Disease

HeartFlow, a California-based start-up that has developed artificial intelligence to diagnose and provide information on coronary artery disease (CAD) based on CT scans, has recently received a $215M financing round led and participated by Bain Capital Life Sciences. The company’s revolutionary products have gained FDA approval, with its first product receiving De Novo clearance in 2014. In light of HeartFlow’s recent financing round and the excitement surrounding it, we have conducted a deep dive into the company, coronary artery disease, and the current US Interventional Cardiology market.

What is Coronary Artery Disease?

Coronary artery disease (CAD), also known as coronary heart disease (CHD), is a type of cardiovascular illness that affects a large number of people. It includes two diseases – myocardial infarction (MI) and angina pectoris, which together account for more than half of all CAD cases.

CAD occurs when the coronary arteries, which are responsible for supplying blood to the heart, become hardened and narrow due to a buildup of plaque on their inner walls. This buildup is called atherosclerosis, and it can restrict blood flow to the heart muscle, leading to serious health problems.

One of the most significant risks of CAD is the possibility of a heart attack, also known as MI. A heart attack can occur when a blood clot suddenly blocks the flow of blood to the heart, causing permanent damage. Additionally, CAD can weaken the heart muscle and contribute to other complications such as arrhythmias and heart failure, where the heart is unable to pump blood effectively to the rest of the body.

Several surgical procedures, under the umbrella of interventional cardiology, can be used to treat CAD, including balloon angioplasty, stent placement, and coronary artery bypass surgery, among others. However, drug-eluting stents can lead to a complication called coronary thrombosis.

How is HeartFlow Combating Coronary Artery Disease?

HeartFlow operates at the crossroads of health and technology, utilizing sophisticated technology to improve healthcare outcomes. Through its innovative product, the HeartFlow FFRCT Analysis, the company aims to establish a new benchmark in the diagnosis and treatment of coronary artery disease. This condition is the leading cause of death worldwide, making HeartFlow’s work of paramount importance.

In 2022, HeartFlow received FDA 510(k) clearance for two of its additional products: Plaque analysis and RoadMap analysis, both of which are AI-powered. HeartFlow has achieved a significant milestone by expanding its product portfolio to offer non-invasive analysis of coronary artery anatomy (RoadMap analysis), physiology (HeartFlow® FFRCT), and plaque information (Plaque analysis) based on CCTA. This makes HeartFlow the sole company in the industry to provide such a comprehensive range of services without the need for invasive procedures.

Currently, according to HeartFlow, 80% of the top 50 US hospitals have adopted HeartFlow and 96% of US commercial lives are covered. With HeartFlow’s products being used in more that 725 hospital systems, there’s no doubt that this technology is changing the game when it comes to addressing and preventing CAD.

What Other Companies are Competing in Interventional Cardiology? 

Within the US, the top three market share leaders of the Interventional Cardiology Market are Boston Scientific, Abbott, and Medtronic. 

Boston Scientific is a highly reputable competitor in the interventional cardiology industry, boasting a strong presence in both the coronary and peripheral markets thanks to its extensive sales force. The company has demonstrated a renewed commitment to capturing the complex PCI market segment, for which it provides a range of specialized devices, including CTO systems, atherectomy devices, specialty balloon catheters, embolic protection devices, IVUS, and FFR.

Abbott is a major player in the interventional cardiology market, ranking as the second-leading competitor. The company has a broad presence across a diverse range of device segments, often ranking at or near the top in each market it participates in. Abbott’s position is particularly dominant in the interventional coronary guidewire market, where its Hi-Torque™ devices have established a strong track record of success. Notably, Abbott faces no current competitors in the OCT market.

Lastly, as of 2022, Medtronic ranks as the third-leading competitor in the interventional cardiology market, frequently occupying a top-tier position in the various segments it operates in. Among these, the company has achieved notable success in the interventional coronary stent market, where it offers a range of product lines, including the Resolute Onyx™ and Resolute Integrity™ DES, as well as the Integrity™ BMS. Medtronic’s strong performance in this sector has established it as a formidable force in the industry.


​​In conclusion, HeartFlow’s innovative technology has made significant strides in the diagnosis and treatment of coronary artery disease, a leading cause of death worldwide. With its recent financing round and the FDA approval of its additional products, HeartFlow is leading the charge in providing comprehensive non-invasive analysis of coronary artery anatomy, physiology, and plaque information, without the need for invasive procedures. As a result, it has gained widespread adoption across top US hospitals, making it a game-changer in addressing and preventing CAD. While Boston Scientific, Abbott, and Medtronic are also formidable competitors in the interventional cardiology market, HeartFlow’s unique approach and comprehensive product offerings should set it apart in this critical field of healthcare.

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Emma MatrickRevolutionizing Coronary Artery Disease Diagnosis: The Rise of HeartFlow