CA-HEARTFLOW,-INC.
2.9.2021 14:02:06 CEST | 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 nneces sary i nvasive coron 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210902005108/en/
About Business Wire
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
VasionⓇ Enhances Global Partner Program to Accelerate AI-Powered Automation24.9.2026 16:05:00 CEST | Press release
A refreshed rewards structure, new Partner Academy, and rebuilt partner portal give partners a clearer path to sell and support agentic print and document workflows. VasionⓇ, the Intelligent Print Automation platform trusted by more than 14,000 organizations worldwide, today unveiled a comprehensive refresh of its Global Partner Program. The program delivers the resources partners expect from Vasion: always-on incentives, structured onboarding, elevated enablement, and a rebuilt portal experience, all engineered to help partners scale, compete, and deliver stronger customer outcomes as agentic AI reshapes how enterprises automate work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924791639/en/ Agentic print and document workflow environments remain an overlooked channel opportunity, as enterprises race toward agentic automation. IDC forecasts that by 2026, 40% of all Global 2000 job roles will involve working with AI ag
The Only AI Crypto Lead Prioritization Solution Built With Law Enforcement, for Law Enforcement: Elliptic Launches Pulse24.9.2026 15:15:00 CEST | Press release
Pulse delivers actionable leads in seconds, no crypto expertise required, enabling decisions in the field Elliptic, the global leader in on-chain risk, today launched Pulse. Pulse puts crypto lead prioritization directly in the hands of every frontline law enforcement and government officer. Crypto now touches every part of law enforcement, from the patrol officer on the street to the detective assigned to investigate the case. Pulse gives each of them a quick, accurate financial summary and a starting point: whether that's a crypto address on a suspect's phone, in a scam ATM victim's receipt, uncovered during a vehicle or pocket search, or found at the scene of an overdose, an arrest, or a seizure. An officer can input anything that looks like a wallet address or transaction hash. Pulse identifies it, reasons over the result, and returns a summary in plain language, enough for the officer to decide on the spot whether the case needs escalation. If a case needs further investigation, o
Just 4.7% of Financial Institutions Continuously Update Their Compliance Monitoring and Controls as Risk Changes, New Research Finds24.9.2026 15:04:00 CEST | Press release
As financial crime threats, regulations and transaction volumes evolve dynamically, most compliance programs remain built around periodic review SymphonyAI, a global leader in vertical AI product platforms, and AML Intelligence, the leading source of news and insight for the financial crime compliance community, today released the FinCrime Frontier 2026–27 Report, finding that most financial institutions still rely on periodic review cycles to manage financial crime risk, even as the threats and regulations they are meant to track continue to evolve dynamically. Based on the perspectives of more than 200 financial crime and compliance leaders, including senior leaders from major global financial institutions, the research finds that just 4.7% of financial institutions continuously update their compliance monitoring and controls as risk changes, while 56.8% have not adopted always-on compliance monitoring at all, are only exploring it, or remain at an early, pilot-stage level. The findi
SymphonyAI Introduces Symphony Risk Intelligence, an Agent-native Platform That Unlocks Always-on Compliance™ — the Catalyst for Transforming the Financial Crime Operating Model24.9.2026 15:04:00 CEST | Press release
New industry research finds just 4.7% of financial institutions continuously update their compliance monitoring and controls as risk changes, a gap regulators are now pushing institutions to close SymphonyAI today introduced Symphony Risk Intelligence (SRI), an enterprise-grade, agent-native platform built to unlock Always-on Compliance™. This is a critical shift from periodic to continuous risk and compliance management, in which institutions continuously reassess risk and adapt controls as regulations, threats and business activity change, rather than waiting for the next scheduled review. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924914614/en/ Current approaches have reached their structural limits. The FinCrime Frontier 2026–27 Report, released recently by SymphonyAI and AML Intelligence, finds just 4.7% of financial institutions continuously update their compliance monitoring and controls as risk changes, and 76
Boomi Appoints Mike Hickman as Chief Financial Officer24.9.2026 15:00:00 CEST | Press release
Three-decade technology finance leader joins Boomi to scale global operations, bringing experience across IPO, take-private, and large-scale acquisition integration Boomi, the data activation company for AI, today announced the appointment of Mike Hickman as Chief Financial Officer. Hickman will lead Boomi's global finance and accounting organization, spanning financial planning and analysis, accounting, treasury, tax, and financial reporting. He reports to Boomi Chairman and Chief Executive Officer Steve Lucas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924761566/en/ Boomi Appoints Mike Hickman as Chief Financial Officer Hickman brings three decades of senior finance leadership in high-growth SaaS and technology companies, with experience across the full corporate lifecycle: scaling through IPO, executing a take-private, and integrating large acquisitions. He joins from Proofpoint, where he spent seven and a half yea
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