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HFSA 2025 Round-Up, Intelerad to the Cloud, and AngioSafe
October 2, 2025
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Together with
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“We have thus entered an era when the evidence linking inflammation with ASCVD is no longer exploratory but is compelling and clinically actionable.”
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Mensah et al.
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As telemedicine becomes more common, cardiologists need a safe, reliable way to help their patients manage heart failure. Watch this episode of the Cardiac Wire Show to find out how Dr. Marc Atzenhoefer, MD of Froedtert & Medical College of Wisconsin uses Abbott’s CardioMEMS device to make sure his patients get intervention when they need it most.
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Cardiac Wire attended its first ever Heart Failure Society of America meeting this year, exploring everything from the latest pharmaceutical advancements to the complex relationship between cardio-renal health and beyond. Here are some of the big takeaways from HFSA 2025.
Heart Failure Comes in Many Forms: While the gold-standard for diagnosing heart failure is still tied to left ventricular ejection fraction, what causes decreased LVEF varies greatly from congenital defects, to cardiometabolic causes, and even gene over-expression. This was reflected in the studies presented by researchers and the solutions offered by companies.
Pharma Has a Strong HF Priority: Among the booths and studies at HFSA, both the research and floor space were dominated by pharma companies, underscoring how many of the treatments for HF focus on either biochemically reducing symptoms, improving quality of life, or addressing the root cause of HF.
Patient Monitoring is Central to HF Treatment: Whether it’s getting the dose right, or making sure a patient’s heart function is steady, one thing was clear from this year’s studies: data drives the decisions clinicians make on the individual level. Stats like serum potassium or arterial pressure vary from patient to patient, so no two HF treatments are really the same.
Transplants are Still Inevitable: Even with all the discussion around how to best treat heart failure, there still isn’t a cure in sight, meaning that the final option for many patients with failing hearts is a transplant.
Many HF Forms Are Still Preventable: Though it may seem like a discouraging takeaway, the lack of a definitive cure for HF highlights just how important prevention is, with the HFSA now moving in the direction of prioritizing prevention rather than just treating it when it happens.
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PIA Medical Processes It All
Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.
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Explore Vitrea Advanced Visualization
Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow
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- Eko EFAST’s FDA Clearance: Eko Health received FDA clearance for its EFAST algorithm for the company’s SENSORA platform. EFAST detects structural heart murmurs and AFib with improved specificity and faster exam times while maintaining high accuracy. Trained on over four million de-identified heart sound and ECG recordings, the foundation model uses supervised fine-tuning for specific clinical tasks.
- Echo AI Classifies Aortic Stenosis: Us2.ai’s echocardiography AI solution was used to classify aortic stenosis severity in research presented at ASE 2025. Researchers used Us2.ai in 954 patients to grade stenosis severity and predict clinical outcomes, finding the company’s gradient boosted model performed well compared to an expert cardiologist, with high accuracy for all cases (74%) as well as low-flow cases (75%). GBM analysis outperformed the cardiologist in predicting a composite of clinical endpoints.
- FDA Mulls Approach to Real-World AI Data: The FDA this week issued a request for public comment on how to evaluate AI’s effectiveness for real-world clinical tasks. The move addresses concerns that positive AI results in clinical studies aren’t replicated in real-world clinical use, due to changes in clinical practice, patient demographics, data inputs, and healthcare infrastructure. The topic came up during the first meeting of the FDA’s Digital Health Advisory Committee in November 2024, and most likely will be discussed at the next DHAC meeting on November 6.
- Intelerad Launches InteleHeart in the Cloud: The cardiac image management segment is red hot, and to stay ahead of the curve, Intelerad announced a new cloud-native version of its InteleHeart cardiology workflow platform. The InteleHeart platform now provides unified cardiac viewing, reporting, analytics, and workflow orchestration in a single package, making it easier for cardiac imagers to manage critical information. Meanwhile, the cloud-native architecture simplifies deployment across multiple care settings while also enabling better integration with the company’s IntelShare and InteleOrchestrator solutions.
- The Sooner, the Better with ATTR-CM: The ATTRibute-CM post hoc analysis presented at HFSA 2025 showed that acoramidis significantly reduced ATTR-CM patients’ cumulative cardiovascular events compared to placebo. Benefits emerged within one month, with treatment preventing 53 events per 100 patients by 30 months and leading to 49% fewer CV events overall. One-fifth of events occurred within six months, emphasizing early diagnosis and treatment importance. It’s worth noting that these outcomes challenge previous assumptions about delayed therapeutic benefits, advocating for sooner ATTR-CM treatment initiation.
- Immunosuppression For Pediatric Heart Transplant: Everolimus could be a suitable alternative to the current immunosuppression standard of tacrolimus plus mycophenolate in pediatric heart transplant patients. Researchers studied 211 children 6 months after their heart transplant and found that everolimus plus low-dose tacrolimus worked equally as well as tacrolimus plus mycophenolate at preventing rejection, blood vessel disease, and kidney disease. However, it also showed extra benefits including better kidney function and fewer viral infections, suggesting it could be an improvement rather than just an alternative.
- WINREVAIR Wins Again: Full results from Merck’s Phase 3 HYPERION trial showed that WINREVAIR (sotatercept) reduced clinical worsening events by 76% versus placebo in recently diagnosed PAH patients. The treatment benefit appeared within six weeks, with 10.6% versus 36.9% experiencing clinical worsening events. Over 70% of patients received double background therapy and WINREVAIR demonstrated significant improvements in multicomponent endpoints as well as REVEAL Lite 2 scores. This represents the third positive Phase 3 study for WINREVAIR in PAH.
- Vutrisiran’s Multi-System Impacts: Alnylam presented its HELIOS-B Phase 3 analyses at HFSA 2025, showing that vutrisiran (AMVUTTRA) reduced gastrointestinal events in ATTR-CM patients. Compared to placebo, patients on vutrisiran experienced a 37-49% reduction in GI events with over 50% fewer occurrences of diarrhea, nausea, and vomiting across treatment groups. A further monotherapy analysis of HELIOS-B demonstrated 32% risk reduction in all-cause mortality and recurrent cardiovascular events, reinforcing vutrisiran’s efficacy as standalone first-line therapy.
- Kardigan’s DCM Drug: Kardigan announced positive Phase 2a results for danicamtiv in genetic dilated cardiomyopathy (DCM) at HFSA 2025. The drug showed significant improvements in left ventricular ejection fraction and left atrial function, particularly in patients with MYH7 and TTN mutations. Danicamtiv was well-tolerated with no serious adverse events. The 41-patient trial supports further investigation in the planned KINSHIP-DCM trial and represents potential progress toward a first-in-class targeted treatment addressing DCM’s underlying sarcomeric dysfunction rather than just symptoms.
- First Implantation of the Relief System: Relief Cardiovascular announced its successful first-in-human implantation of the Relief System, marking the world’s first implant combining hemodynamic monitoring with active congestion treatment for heart failure. The transcatheter device features a pressure-guided valve in the vena cava that dynamically reduces cardiac preload and enhances renal flow while automatically syncing data to the cloud. Relief claims this approach scales personalized HF management beyond small cohorts requiring manual pressure monitoring and medication adjustments.
- AngioSafe Emerges with CV Plaque Treatment: A new plaque treatment competitor, AngioSafe emerged from stealth with FDA 510(k) clearance and CE marking for its Santreva-ATK wire-free, power-free, chronic total occlusion crossing system. The device enables simultaneous plaque compression and vessel recanalization in femoropopliteal arteries and was supported by the RESTOR-1 pivotal study that demonstrated 90% success with no device-related major adverse events and >55% mean lumen gain. AngioSafe’s U.S. commercial launch will begin this month.
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GLS Analysis of Us2.ai’s Fully-Automated Software
Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.
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Personalized Plaque Analysis Now With Medicare Coverage
Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
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A Solution for Your Entire Cardiology Service Line
The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.
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- Changes in Heart Failure Management: Heart failure is a complex condition with high heart failure hospitalization and cardiovascular mortality rates, especially among patients with HFpEF and HFmrEF, for whom treatment options have been limited. Read how Bayer’s Dr. Alanna Morris-Simon discusses the changing treatment landscape and strategies for improving patient outcomes.
- Siemens Healthineers ACUSON Origin Ultrasound System is Redefining CVUS: ACUSON Origin meets the demands of today’s cardiovascular care with AI-powered efficiency across adult and pediatric echo, vascular, structural heart, and EP. Streamlined workflows, intuitive walk-up usability, and advanced ergonomics empower clinicians to deliver confident, high-quality care—supporting a wide range of complex cases and clinical applications.
- How Vista AI Helps Solve the Technologist Shortage: Fewer than 2% of MRI scanners are routinely used for cardiac imaging—mainly due to a shortage of trained technologists amid rising demand. Vista AI addresses this challenge by automating CMR scanning, empowering technologists of all experience levels to deliver high-quality cardiac exams consistently and efficiently.
- Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.
- Median Survival for HeartMate 3 LVAD Patients Exceeds 5 years: Find out why for select transplant-eligible patients, the HeartMate 3 LVAD and heart transplant can be used as complementary therapies, resulting in net prolongation of life and even extending many patients’ lives 10+ years.
- Accurate and Efficient Remote Cardiac Patient Monitoring: The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show episode, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.
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