|
Myval’s TAVR LANDMARK, Oral PCSK9i Success, and EchoPrime
November 20, 2025
|
|
|
|
|
Together with
|
|
|
|
“I travel with black electrical tape just to silence blinking hotel lights and clocks that insist on acting like miniature lighthouses. I avoid lights in my bedroom at home at all cost.”
|
|
Kenneth Civello, MD
|
|
|
The heart failure treatment landscape continues to change for adults with heart failure with a left ventricular ejection fraction of 40% or more. Watch this episode of the Cardiac Wire Show to hear from Dr. Andrew Sauer about the approaches shaping patient care. #Sponsored
|
|
|
|
The TAVR race might be closer to having another competitor in North America, after the LANDMARK trial’s one-year results suggest that Meril’s Myval THV series achieved comparable clinical efficacy to both Edwards’ Sapien and Medtronic’s Evolut AVR systems.
- So far, the TAVR market has been dominated by established balloon-expandable (Sapien) and self-expanding (Evolut) valve systems.
- Myval THV is a balloon-expandable system that features a hybrid honeycomb design for better hemodynamic performance and minimizing paravalvular leak.
- While Meril’s Myval has gained CE mark in the E.U. the device is still undergoing the FDA’s premarket approval process in the U.S.
The LANDMARK trial enrolled 768 patients with symptomatic severe aortic stenosis at 31 sites across 16 countries, randomizing them to the Myval, Sapien, or Evolut systems and found that…
- Composite clinical efficacy (freedom from all-cause mortality, stroke, and hospitalization) was 87% for Myval versus 86.9% for both Sapien and Evolut, demonstrating statistical noninferiority.
- Extended clinical efficacy including quality-of-life deterioration showed consistent results: 80.5% for Myval, 75.0% for Sapien, and 79.7% for Evolut.
- Myval demonstrated the lowest moderate aortic regurgitation incidence at 1.6%, which is a marker of hemodynamic stability and long-term valve performance.
- In small aortic annulus patients, composite efficacy was similar: 91% for Myval versus 89% for Sapien and 91% for Evolut.
In a field dominated by established platforms with decades of experience, Meril believes that LANDMARK provides comparative insight by evaluating the valves against two leading systems under identical conditions.
- Specifically, Myval’s low aortic regurgitation rate is important as TAVR expands to younger, lower-risk patients who need durable long-term outcomes.
The trial’s investigators have also committed to a 10-year follow-up study to provide critical durability data, since valve longevity is becoming increasingly important for treatment decision-making.
- This means that the trial’s geographic diversity and inclusion of challenging anatomies like small annulus will strengthen the long-term data’s real-world generalizability.
The Takeaway
Though it’s only one year worth of results from LANDMARK, the early data suggests that Meril’s Myval performs similarly to incumbents and it might have a slight edge in hemodynamic stability. That said, the device still has a decade of data to catch up to from its competitors, so we’ll need to wait and see until its FDA approved before jumping to conclusions.
|
|
Circle CVI’s CAD-RADS Rundown
Ever wondered how CAD-RADS enhances the communication of coronary artery disease findings from imaging studies? Check out this guide from Circle Cardiovascular Imaging about the evolution of CAD-RADS and how to incorporate it into your practice.
|
|
Us2.ai’s AI HF Now Possible with Handheld Echo
The latest research shows Us2.ai’s software can take handheld echocardiography beyond its standard applications. Read this EHJ study about how swiftly and accurately Us2.ai’s HF detection software detects LVEF, closely matching expert human analysis of standard cart based echocardiograms.
|
|
9 Merge Cardio Features to Change Your Cardiology Workflows
Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.
|
|
- Arrowhead’s siRNA Notches FDA Approval: The FDA approved Arrowhead Pharmaceuticals’ REDEMPLO (plozasiran), making it the first siRNA medicine for familial chylomicronemia syndrome (FCS). Administered quarterly via subcutaneous injection, REDEMPLO demonstrated 80% median triglyceride reduction versus 17% for placebo in the Phase 3 PALISADE study. This marks Arrowhead Pharmaceuticals’ first FDA-approved therapy using its TRiM platform. The company launched a patient support program, with U.S. availability expected before year-end.
- A New Endovascular Robot: Stereotaxis received FDA 510(k) clearance for its GenesisX endovascular surgical robotic system. The robot features integrated magnetic shielding, operates on standard power, requires no structural anchoring, and has an 80% smaller cabinet, enabling installation in existing catheterization labs without construction. The GenesisX system is currently undergoing limited launches in the U.S. and Europe while expanding compatible catheters and commercial processes. This marks Stereotaxis’s second robotic system in five years.
- Philips’ MVR Guidance Tech: Philips introduced DeviceGuide, an AI-powered device tracking solution that assists physicians during minimally invasive mitral valve repairs. Built on the EchoNavigator platform, it automatically tracks repair devices in real-time, creating 3D virtual models superimposed on live heart images. Developed with Edwards Lifesciences, DeviceGuide helps clinicians navigate beating hearts with enhanced visualization during procedures treating mitral valve regurgitation.
- Vutrisiran’s 3 Year Results: Alnylam released data from its HELIOS-B Phase 3 post-hoc analyses that support vutrisiran’s (AMVUTTRA) long-term benefits for ATTR-CM patients. The study used CMR imaging to examine patients across three years of treatment and showed amyloid regression in 22% of vutrisiran-treated patients versus 0% with placebo at Year 3, with improvements in cardiac structure and function. Vutrisiran also preserved kidney function, reducing risk of death and cardiovascular events in advanced chronic kidney disease patients (HR: 0.47).
- BSCI and Siemens for Structural Heart: Boston Scientific partnered with Siemens Healthineers to develop and commercialize Siemens’ next-generation ACUNAV 4D intracardiac echocardiography (ICE) catheter. The technology provides real-time three-dimensional heart imaging without crossing into the left atrium, avoiding potential complications. Intended for WATCHMAN left atrial appendage closure, FARAWATCH procedures, and other structural heart interventions, the partnership aims to expand procedural adoption and improve workflow efficiency. Boston Scientific will exclusively distribute ACUNAV 4D ICE in the United States and Japan once commercially available.
- Merck’s PCSK9 Success: Merck announced its Phase 3 CORALreef Lipids trial results showing that its oral PCSK9 inhibitor enlicitide is effective after six months to a year of use. According to the study, patients on enlicitide achieved a statistically significant 55.8% LDL-C reduction at 24 weeks versus placebo. The drug also reduced non-HDL cholesterol, apolipoprotein B, and lipoprotein(a), and at one year, and 67.5% of patients achieved rigorous cholesterol goals. If approved, enlicitide would be the first oral PCSK9 inhibitor.
- CCTA Reveals Hypertension’s Early Risk: Adolescents with high blood pressure had higher rates of atherosclerosis on coronary CT angiography scans some 40 years later. In a new JAMA Cardiology study, researchers followed 10.2k Swedish military conscripts who got blood pressure readings at about 20 years old. CCTA exams were performed at a median age of 58, finding that those with stage 2 hypertension in adolescence had 84% higher odds of severe coronary stenosis in middle age, as well as higher stenosis prevalence (10.1% vs. 6.9%).
- Keep Your Nights Dark: Exposure to lights at night could significantly raise your CV risk. A recent study of 88k adults aged 40+ tracked light exposure for nearly a decade and found that those with the brightest nighttime light exposure (91st-100th percentiles) showed significantly elevated risks for coronary artery disease, myocardial infarction, heart failure, atrial fibrillation, and stroke compared to those with dark nights. The findings suggest that minimizing nighttime light exposure may be an effective preventive strategy for reducing cardiovascular disease risk.
- EchoPrime Shows Promise: New research suggests that EchoPrime, an AI model trained on over 10M echocardiography videos could provide comprehensive echocardiogram interpretation using vision-language capabilities. Published in Nature, the AI achieved mean AUCs of 0.85-0.92 across multiple institutions, outperforming existing single-task models without additional training while generating free-text reports rather than yes/no responses. Developers hope it will address shortages in sonographers and cardiologists, democratizing cardiovascular care access. Clinical testing on 1,200 echocardiograms is currently underway, with results expected late 2026.
- How Do You Feel in the Cath Lab? A national poll by W.L. Gore & Associates and Egg Medical revealed widespread concern about radiation exposure among physicians performing image-guided procedures. All interventional cardiologists, 96% of interventional radiologists, 93% of vascular surgeons, and 71% of cardiac surgeons expressed concern. Despite this, fewer than 30% feel “very protected,” and adoption of advanced protection varies significantly by specialty. The companies are partnering to expand access to radiation protection solutions including Egg Medical’s EggNest System.
- GE’s Flyrcado Adopted by CVAUSA: GE HealthCare announced that CVAUSA, the largest U.S. private cardiology network, plans to broadly adopt its Flyrcado (flurpiridaz F18) cardiac PET radiotracer, across approximately 25 sites following a successful 21-patient pilot. The pilot demonstrated seamless workflow integration in high-volume settings with enhanced diagnostic confidence and image quality. Other recent Flyrcado milestones include a distribution agreement with CDL Nuclear Technologies and inclusion in new international procedure standards by major cardiology societies.
|
|
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
|
|
Heartflow Roadmap Analysis For Efficient Care
As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.
|
|
Heart Failure Hospitalization Doubles Risk of Cardiovascular Death
21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% of those who experience hospitalization are readmitted due to heart failure within one year of discharge. Watch Bayer’s Dr. Alanna Morris-Simon discuss heart failure hospitalizations and when to assess care plans.
|
|
- Vista AI Grows CMR Volume: Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.
- 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.
- 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.
- Why Competitors Benchmark Against Monebo’s ECG Algorithm: In the world of cardiac monitoring, it’s a big deal when your competitors use your technology as their benchmark for success. Learn why Monebo Technologies’ ECG analysis algorithm has been the “predicate device” of at least 13 other companies FDA 510(k) clearance regulatory filings and what this means for providers and their patients.
- 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.
|
|
|
|
|
