|
ODYSSEY vs. MAPLE, ESC Studies, and Kardium’s FDA Approval
September 4, 2025
|
|
|
|
|
Together with
|
|
|
|
“Over the past few days, at this congress in Madrid, you have once again provided us with a valuable example of dialogue, because cardiovascular health… is a global challenge and because knowledge, when it contributes to progress, should encounter no borders…”
|
|
King Felipe VI of Spain giving his closing speech at ESC 2025.
|
|
|
Cardiology Pharmaceuticals
|
|
|
|
|
|
In a big step towards better hypertrophic cardiomyopathy treatments, two separate studies presented at ESC suggest cardiac myosin inhibitors’ efficacy depends critically on whether patients have the obstructive or nonobstructive form of the disease.
- Cardiac myosin inhibitors like aficamten (Cytokinetics) and mavacamten (Bristol-Myers Squibb) treat HCM by reducing hypercontractility.
- Current guidelines recommend adding these medications after beta-blockers or calcium channel blockers fail, but beta-blocker efficacy in HCM has been limited despite decades of use.
- There are two forms of HCM: obstructive which leads to thickened heart muscle that blocks blood flow out of the heart, and nonobstructive which leads to muscle thickening without impairing blood flow.
Two similar but different trials presented contrasting outcomes at ESC 2025, with MAPLE-HCM testing aficamten versus metoprolol in obstructive HCM patients, and ODYSSEY-HCM testing mavacamten versus placebo in nonobstructive HCM.
- On one hand, MAPLE-HCM found Cytokinetics’ aficamten led to a 2.3 mL/kg/min improvement in peak oxygen uptake, plus better outcomes in NYHA class, quality of life scores, and LVOT gradients compared to metoprolol.
- On the other hand, ODYSSEY-HCM found that BMS’ mavacamten led to non-significant improvements in peak oxygen uptake (0.47 mL/kg/min difference) and QoL compared to placebo.
Safety profiles across the two studies were quite different, with aficamten showing comparable adverse events in MAPLE-HCM (8% vs 7%), while mavacamten saw more treatment interruptions (14.6% vs 5.2%) and LVEF reductions in 21.5% of treated patients in ODYSSEY-HCM.
Even with mavacamten’s nonobstructive setback, cardiac myosin inhibitors might finally help shift HCM treatment paradigms, with MAPLE-HCM potentially supporting the drug’s use as a first-line monotherapy in obstructive disease.
With the clear obstructive versus nonobstructive divide, the future of cardiac myosin inhibitors may depend on precision medicine approaches and drug-specific advantages.
- For example, aficamten offers potential advantages over mavacamten including shorter half-life for easier monitoring, though its FDA approval is still pending.
- With how complex nonobstructive HCM is, treating it with cardiac myosin inhibitors may require identifying specific physiological subgroups to be more effective.
The Takeaway
These pivotal trials suggest cardiac myosin inhibitors could be the future first-line therapy for obstructive HCM while highlighting the complexity of the disease’s nonobstructive form. That said, the data seems to already support replacing decades-old beta-blocker therapy as a first line treatment.
|
|
Relieving The Burden of Post-Processing
With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
|
|
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.
|
|
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.
|
|
- Novartis Goes Big on Argo: Novartis signed a $160M upfront deal with Chinese biotech Argo Biopharmaceutical to develop new cardiovascular siRNA therapeutics. The agreement covers ANGPTL3 (a phase 2 dyslipidemia treatment), a preclinical liver-delivered siRNA candidate, and two discovery-stage molecules for lipid disorders. With the new deal, Argo could receive up to $5.2B in total payments plus royalties, which expands upon the duo’s January 2024 partnership worth $185M.
- Kardium’s Globe Earns FDA Approval: Kardium received FDA approval for its Globe Pulsed Field System, making it the only integrated cardiac mapping and ablation system that enables single-shot pulmonary vein isolation for AFib. The Globe combines high-density mapping and PFA in one 122-electrode spherical catheter, offering more efficient AFib treatment. Kardium’s approval is a result of strong clinical data that showed 78% freedom from atrial arrhythmia at one year in paroxysmal AFib patients, with zero device-related safety events.
- AccurKardia’s AI-ECG at ESC: AccurKardia presented two studies at ESC that show how AI-ECG can identify future TAVR recipients and predict TAVR outcomes. In the first study, researchers found that AccurKardia’s AI-ECG software could identify high-risk AS patients as early as 4.5 years before they underwent TAVR. The second study found that changes in AI-ECG scores around the time of TAVR predicted one-year outcomes like mortality, pacemaker need, and length of stay, pointing to a simpler way of flagging patients at higher risk right after their procedure.
- Pfizer Discontinues Vyndaqel: Pfizer is discontinuing Vyndaqel (low-dose tafamidis) in the U.S. by the end of 2025, leaving only its Vyndamax formulation (high-dose) available. Both treat ATTR-CM with identical benefits, but Vyndamax offers convenience as a once daily capsule versus four for Vyndaqel. Currently under 20% of prescriptions are Vyndaqel and the move comes as Vyndaqel’s patent is set to expire in 2028 alongside intensifying competition from BridgeBio’s Attruby and Alnylam’s Amvuttra.
- Body Fat and the Heart’s Age: Want to know how old your heart is? Check how much body fat you have and where. A new machine learning study found that visceral fat, muscle fat infiltration, and liver fat were strongest predictors of accelerated cardiovascular aging in both sexes. However, abdominal subcutaneous fat and android fat increased aging only in males, while gynoid fat was protective. As a result, researchers believe targeted interventions based on adipose tissue location could extend healthy lifespan.
- GE’s Vivid Pioneer: GE HealthCare launched the Vivid Pioneer, its most advanced cardiovascular ultrasound system. Launching with a CE Mark and FDA clearance, the CVUS system features next-generation cSound Pioneer architecture while delivering enhanced 2D, 4D imaging, and color flow capabilities. It offers 360% faster AI performance with automated tools like AI Cardiac Auto Doppler and Easy AFI for rapid strain analysis.
- Corsera Joins PCSK9 Race: Corsera Health launched with over $50M raised to support its mission to prevent cardiovascular disease through early intervention. The company is developing Klotho Health, an AI tool for predicting lifetime cardiovascular risk, and a once-annual preventive RNAi medicine targeting PCSK9 and angiotensinogen to lower cholesterol and blood pressure. Corsera says clinical trials for its PCSK9 therapy will begin by the end of 2025.
- Pure Safety from VARIPURE: Johnson & Johnson MedTech announced results from its VARIPURE substudy at ESC, confirming that its VARIPULSE pulsed field ablation platform is safe and effective for AFib treatment. The study examined 791 patients and showed strong safety, with 0.6% primary adverse events and no strokes. VARIPULSE also achieved 99.7% acute pulmonary vein isolation success with high procedural efficiency. These results add to the earlier REAL AF Registry that found no strokes, deaths, or device-related hospitalizations.
- Abbott’s Navitor Gets CE Mark: Abbott received CE Mark approval for expanded use of its Navitor transcatheter aortic valve implantation system in low- and intermediate-risk patients with severe aortic stenosis. The approval stems from the VANTAGE trial which showed excellent safety (2.3% mortality/disabling stroke), high technical success (97%), and low paravalvular leak rates (13.6% mild, 0% moderate/severe). The expansion to lower risk AS patients puts Abbott’s Navitor system in a similar position to Edwards’ Sapien platform in the U.S.
- Ionis’ Olezarsen Nails Phase 3: Ionis Pharmaceuticals announced positive Phase 3 results for its drug olezarsen that treats severe hypertriglyceridemia (sHTG). The results come from the CORE and CORE2 studies that showed olezarsen achieved up to 72% placebo-adjusted reduction in fasting triglycerides and 85% reduction in acute pancreatitis events. Both the 80mg and 50mg monthly dose groups met the studies’ primary endpoints and over 90% of patients continued into extension studies.
- Merck’s CORALreef Results: Merck unveiled encouraging Phase 3 results from its CORALreef Lipids trial examining its PCSK9 inhibitor, enlicitide. The once-daily oral treatment led to statistically significant LDL cholesterol reductions versus placebo at Week 24 in patients with hypercholesterolemia on statins while also reducing non-HDL cholesterol, apolipoprotein B, and lipoprotein(a). Patients on enlicitide experienced few adverse events with low discontinuation rates.
|
|
Discover Innovation in Intervention
Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)
|
|
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
|
|
The Largest Registry on Plaque Analysis in CAD
What if 50% of your CCTA patients could benefit from an adjustment to their treatment plan? Read more about Heartflow’s DECIDE registry that demonstrates how Heartflow Plaque Analysis using its Plaque Staging software empowers physicians with clinical insights that lead to real-world impact.
|
|
- Siemens Healthineers’ Cardiac Ultrasound Efficiency S&T Theater at ASE 2025: Looking to reduce your exam times and ergonomic movement during cardiac ultrasound? Sign up to have lunch with Siemens Healthineers’ experts while learning how the AI-powered tools on the ACUSON Origin ultrasound system deliver consistent, reliable measurements with minimal need for manual edits.
- Merge Hemo Expands to Puerto Rico: Merge partnered with Alpha Biomedical to bring Merge Hemo to Puerto Rico, marking the software’s first expansion outside the 50 U.S. states. Read more about the work Merge is doing to expand access to its award winning solutions beyond the United States.
- Discover The Monebo Advantage: Need complex ECG monitoring algorithms for use in a variety of applications? Here are just a few reasons why companies across the healthcare spectrum rely on Monebo to power their ECG monitoring and analysis.
- A New Era of Precision and Efficiency: Ready to enhance your cardiovascular imaging precision and efficiency? See how Circle Cardiovascular Imaging’s new cvi42 6.1 platform is bringing CT and MR imaging under a single platform.
- CMR Access Is Broken—Here’s How to Fix It: Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.
|
|
|
|
|
