HeartFlow Announces Enrollment of First Three Patients in FUSION Trial
2.9.2021 15:00:00 EEST | Business Wire | Press release
HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced that physicians at Erasmus MC Hospital (Rotterdam NL) have enrolled the first three patients in the FUSION (Addition of F FRct in the diagnostic pathway of patients with stable chest pain to reduce u nnece s sary i nvasive cor on ary angiography) randomized controlled trial. The FUSION trial, which is supported by the National Health Care Institute of the Netherlands (subsidieregeling Veelbelovende zorg: Zorginstituut Nederland / ZonMw), will evaluate whether the use of the HeartFlow FFRct Analysis as part of a coronary diagnostic pathway is effective in reducing unnecessary invasive coronary angiograms (ICAs).
Each year, 180,000 patients in the Netherlands visit a cardiologist with complaints of chest pain.1 As part of the diagnostic pathway, patients typically receive a coronary computed tomography angiogram (CTA) to determine if there is a stenosis or narrowing in the coronary artery. The degree to which a narrowing is causing chest pain is not always clear from a coronary CTA alone and patients are often sent for an ICA. Over half of patients who undergo an ICA are found to have no coronary disease or only non-obstructive disease2, making the ICA unnecessary in retrospect.
“By combining the functional information provided by HeartFlow FFRct with the anatomical information from the coronary CTA, we will be better able to assess non-invasively which patients require further invasive investigation,” said Ricardo Budde, MD, PhD, Associate Professor and Principal Investigator of Cardiovascular Imaging, Erasmus MC Hospital. “With the FUSION trial, we anticipate a 33% reduction in unnecessary ICAs which we believe will lead to cost savings for the overall healthcare system.”
The FUSION trial is planned to enroll 528 patients from six Dutch hospitals including Erasmus MC, UMCG, UMC Utrecht, the Admiraal de Ruyter Hospital in Goes, St Jansdal in Lelystad and Gelre hospitals Apeldoorn. Patients whose CTA shows coronary artery disease will be randomized between the HeartFlow FFRct arm or the ICA arm. The primary endpoint is the rate of unnecessary ICAs as reflected by ICAs without an obstructive coronary stenosis defined as an anatomical narrowing >50% or invasive FFR ≤0.80. Once the trial is complete, it is anticipated that the data will support insurance reimbursement in the Netherlands for the HeartFlow Analysis.
“Both in clinical trials and real-world clinical practice, we have seen that the use of the HeartFlow Analysis in a coronary diagnostic pathway delivers a significant reduction in invasive angiograms which are in retrospect unnecessary,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “We anticipate the FUSION trial will deliver similar outcomes to our previous studies and look forward to working with the National Health Care Institute to make the HeartFlow Analysis available to patients in the Netherlands in the near future.”
About the HeartFlow FFRct Analysis
Starting with a standard coronary computed tomography angiogram (CTA), the HeartFlow Analysis leverages deep learning and highly trained analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and provides FFRct values along the coronary arteries. This information helps physicians evaluate the impact a blockage may be having on blood flow and determine the optimal course of treatment for each patient. A positive FFRct value (≤0.80) indicates that a coronary blockage is impeding blood flow to the heart muscle to a degree which may warrant invasive management.
Data demonstrating the safety, efficacy and cost-effectiveness of the HeartFlow Analysis have been published in more than 425 peer-reviewed publications, including long-term data out to five years. The HeartFlow Analysis offers the highest diagnostic performance available from a non-invasive test.3 To date, clinicians around the world have used the HeartFlow Analysis for more than 100,000 patients to aid in the diagnosis of heart disease.
About HeartFlow
HeartFlow is the leader in revolutionizing precision heart care, uniquely combining human ingenuity with advanced technology. HeartFlow’s non-invasive HeartFlow FFRct Analysis leverages artificial intelligence to create a personalized three-dimensional model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. HeartFlow’s technology is reflective of our Silicon Valley roots and incorporates over two decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, UK, Canada, Europe and Japan. For more information, visit www.heartflow.com.
- Nederland Z. Verbetersignalement pijn op de borst (verdenking) stabiele angina pectoris. 2017 12-12-2017.
- Patel, et al. N Engl J Med 2010. Patel, et al. AHJ 2014. Danad, et al. JAMA Cardiology 2017.
- Driessen, R., et al. Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis. J Am Coll Cardiol. 2019;73(2),161-73.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210902005108/en/
Contact information
For Investors:
Leigh Salvo or Jack Droogan
Gilmartin Group
Investors@heartflow.com
For Media:
Jennie Kim
HeartFlow
jekim@heartflow.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Taktile Secures $110M in Goldman Sachs-led Series C to Power AI Transformation in Financial Institutions24.6.2026 16:30:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced its $110 million Series C fundraise. Growth Equity at Goldman Sachs Alternatives led the round, with participation from Balderton Capital, Index Ventures, Tiger Global, Y Combinator, and Dig Ventures. Taktile Fast Facts Taktile enables banks and insurers to transform into AI-native organizations that are increasingly powered by autonomous agents. Demand for Taktile accelerated in 2025, as AI models became capable of automating high-stakes decisions that previously required hours of manual work—from underwriting business loans and assessing claims to catching financial crime. Customers automate and optimize decisions with Taktile by combining its financial services expertise and product built for sector-specific AI use cases. One of the world’s largest insurers is running multiple use cases on Taktile, with projected cost efficiencies of over $90M in claims processing alone. Taktile’s team has a proven
New MetLife Study Reveals a 72% “Confidence Gap” in Ability to Recover from Life's Setbacks24.6.2026 16:25:00 EEST | Press release
A new multinational study from MetLife reveals a striking “confidence gap”: while most adults describe themselves as resilient, their confidence drops by 72% when faced with real-life setbacks. The Confident Pathways Report, conducted across the United States, United Kingdom, Japan, and Mexico, was designed to better understand how confidence is built and sustained throughout life. The findings underscore the role of opportunity, preparedness, and support in building confidence - factors that help people navigate uncertainty, recover from setbacks and pursue their goals. At a time when soccer is bringing people and communities together around the world, the findings also highlight how early childhood experiences such as sports, education, and mentorship can help foster resilience and gain confidence from a young age. Key findings across the four countries surveyed include: Confidence drops by 72% when adults consider their ability to recover from setbacks. Respondents were far more lik
StatLab Launches CytoPath Disc, Advancing Standardized Cell Block Preparation Worldwide24.6.2026 16:08:00 EEST | Press release
StatLab Medical Products, a leading global developer and manufacturer of pathology supplies and equipment, today announced the global launch of the CytoPath Disc, an innovative cell block preparation technology designed to standardize and simplify cell block preparation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624368623/en/ Developed as an alternative to traditional cell block methods, which convert concentrated cells suspended in fluid into a paraffin-embedded format for slide-based evaluation, the patent‑pending CytoPath Disc offers a more streamlined and efficient approach. The CytoPath Disc absorbs concentrated cells within a simple, sponge-like matrix, which is then processed, embedded, stained, and sectioned using standard histology workflows. Traditional cell block preparation methods often present challenges in achieving consistent results due to complex procedures, as well as the need for additional equipm
TensorX Launches With €8M Seed Funding Round Led by Darius Cubed Ventures for Bet on European Sovereign AI Infrastructure With Plans to Deploy up to €100M in NVIDIA Blackwell GPUs24.6.2026 16:07:00 EEST | Press release
A team of Irish founders has committed €8 million to Nvidia Blackwell GPUs, including the latest B300 chips, to launch TensorX, a sovereign AI inference platform designed for Europe's AI builders, trusted by regulated industries and already generating revenue from paying customers. The company was founded by Shane Morton, is part of the NVIDIA Inception program and is partnering with Dell on sourcing GPU hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528791384/en/ (From left to right): Craig Donnelly, Shane Morton, Nicole Morton, Tim Grant At a time when enterprises are racing to adopt artificial intelligence but most remain unwilling to let their data leave European jurisdiction, TensorX offers high-performance inference with zero data retention, running entirely on dedicated hardware in Dublin and Helsinki. TensorX is also in advanced talks around a financing facility to further expand its European footprint,
Clearwater Analytics Benchmarks Private Credit Strategy, Performance, and Risk Across Institutional Portfolios24.6.2026 16:00:00 EEST | Press release
Clearwater Analytics (NYSE: CWAN) today released Credit Where It’s Due: The Persistent Rise of Private Credit, its first comprehensive study of how private credit has reshaped institutional portfolios. The report draws on holdings and transactions data from the Clearwater platform, which spans $10 trillion in institutional assets across 60 asset classes. It documents private credit exposure, examines how the asset class has contributed to returns, and identifies where investment risks concentrate. The findings challenged a narrative centered on systemic contagion. Instead it found the systemic risks were idiosyncratic, concentrated on specific balance sheets that are largely hidden from investors without the right infrastructure. “At Clearwater, we are no strangers to the rise of private credit. Assets on our platform have grown nearly 20% over the last two years alone,” said Kirat Singh, President of Risk and Alternative Assets at Clearwater Analytics. “This report was born from what
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom