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A Polymer Mitral Valve Success and More From NYV 2025
June 30, 2025
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Together with
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“Heart disease is still the #1 killer in the United States, but it’s no longer from heart attacks… instead it’s from heart failure and arrhythmias.”
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Eric Topol, MD
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Cardiac Wire attended its first ever New York Valves conference last week and we had the pleasure of meeting with Dr. Hemal Gada, MD, MBA to briefly chat about his passion for TAVR and his insights on everything from research to where the space is headed. You can watch the exclusive interview here.
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The valve replacement space keeps adding contenders, and Foldax’s polymer-based TRIA Mitral Valve replacement showed compelling one-year results in its India Clinical Trial presented at New York Valves 2025, suggesting we could soon have an alternative to bovine tissue valves.
- Foldax’s TRIA surgical mitral valve recently received commercial use approval in India, making it the first polymer heart valve to go to market anywhere in the world.
- TRIA is built using LifePolymer, which doesn’t include animal tissue and its leaflets and frame are robotically generated to match each patient’s native mitral valve.
- The new polymer helps reduce valve calcification and could potentially allow patients to avoid long-term anticoagulant use.
Researchers tested the new surgical TRIA polymer valve on 67 patients (aged 19 to 67) across India and found that the mitral valve replacement led to no valve-related mortality or reinterventions, among other encouraging results like…
- A >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg).
- A >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies.
- 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant QoL improvements.
When it came to adverse outcomes, only two thrombotic events and three ischemic strokes occurred, all in patients with subtherapeutic vitamin K antagonist levels.
While these results are encouraging, Foldax’s TRIA still has to contend with some of the biggest medtech companies in the world, many of which already have a start in the MV space.
- For example, Abbott already produces the MitraClip for mitral valve repair and the Tendyne transcatheter mitral valve replacement system.
- Meanwhile, Edwards Lifesciences manufactures the MITRIS RESILIA surgical mitral valve and the PASCAL transcatheter valve repair system.
The Takeaway
A new mitral valve replacement option might be on the way following these successful trial results, but it’s still an uphill climb for Foldax to gain U.S. regulatory approval and then compete in a market dominated by medtech giants. Still, its innovative polymer and custom profile might give TRIA a chance.
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Explore the latest clinical evidence: SMART Trial 2-year results are in!
Evolut™ TAVR maintains superior valve performance through two years in small annulus patients. Dive
into the key findings from the latest SMART Trial results. View now!
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Cut Waste with GE HealthCare’s Inventory Management
Want to make your hospital’s inventory practices more efficient? Tune in to this webinar on how GE HealthCare’s data-driven insights can optimize inventory management and reduce cardiac procedure times by 30-45 minutes.
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Left Ventricular Devices Have Received Level 1A Recommendation
Patients on long-term inotrope support have a median survival of under a year.
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- Lead Complications and TTVR: Presented at New York Valves, data from the TRIPLACE study suggests TTVR is safe and effective in patients with existing cardiac device leads, despite challenging complications. Among 379 patients studied, 30-day outcomes were comparable regardless of lead presence, but patients with “jailed” leads experienced significantly higher long-term failure rates (5.9% vs. ~3%). Experts emphasize that electrophysiologists should be included in heart valve teams, because better communication and even lead extraction could reduce valve complications.
- Cardiosense’ SEISMIC Results: Cardiosense published results from its SEISMIC-HF I study, showing that its AI algorithm can noninvasively estimate pulmonary capillary wedge pressure in HF patients. The 310-patient study confirmed that the company’s CardioTag wearable device has accuracy comparable to implantable sensors while performing consistently across diverse demographics. This breakthrough could make hemodynamic-guided heart failure care more accessible by eliminating the need for invasive cardiac catheterization procedures.
- Florida Mandates Youth ECGs: Florida became the first U.S. state to require ECG screenings for high school athletes after passing The Second Chance Act. Starting in 2026, students in grades 9-12 must complete ECG screening before participating in sports to help screen for the 1 in 300 youth living with undiagnosed heart conditions that can cause sudden cardiac arrest. Since ECGs can detect up to 80% of related conditions versus 10-20% from traditional physicals, overall detection could improve to 94%.
- Novartis’ ProFound Deal: Novartis signed a four-year partnership with ProFound Therapeutics to develop cardiovascular disease treatments, offering $25M upfront plus $750M in potential milestones per target. The collaboration will use ProFound’s protein detection platform to identify new therapeutic proteins and expand CV treatment options. Novartis currently markets heart drugs Entresto and Leqvio, while ProFound previously partnered with Pfizer on obesity drug development through Flagship Pioneering’s portfolio.
- Navitor’s Vision into the Future: Abbott’s Navitor Vision TAVR system showed improvements over the Navitor Classic in a recent U.S. commercial use study presented at New York Valves. The newer device reduced 30-day mortality/stroke rates (4.9% vs. 5.2%) and major vascular complications (1.5% vs. 1.9%). Permanent pacemaker rates remained at 17.8% overall, but dropped to 12.3% in patients without baseline conduction defects and just 10.6% at high-volume centers, demonstrating improved outcomes with more experienced providers.
- FDA Warning for COVID Vax: The FDA expanded warnings on Pfizer and Moderna’s COVID-19 vaccines regarding myocarditis. The updated labels specify 8 myocarditis cases per million vaccinated people aged 6 months to 64 years, most commonly affecting males 12-24. Curiously, this conflicts with CDC findings showing no increased myocarditis risk since 2022. The change comes as HHS Secretary RFK Jr.’s new vaccine advisory panel debates continued COVID vaccine use amid broader vaccine restrictions by the administration.
- Wildfire Smoke is Extra Dangerous: A national JACC study of 22M Medicare beneficiaries found that wildfire smoke particles increase heart failure risk more than conventional air pollution. Each 1 μg/m³ increase in fire smoke exposure raised heart failure risk by 1.4% versus 0.5% for non-fire particles. This corresponds to approximately 20k additional annual heart failure cases among older adults, with women and socioeconomically vulnerable populations facing heightened risk.
- TAVR – Explant or Redo? According to data presented at New York Valves, TAVR patients who need reintervention benefit more from surgical explants than redo TAVR procedures. While 30-day mortality was higher for explant (15.3% vs. 4.9%), a survival advantage emerged at 1.8 years and persisted through 6-year follow-up. Explantation showed particular benefit in patients aged 65-70 and required fewer secondary reinterventions (6.2% vs. 31.2%), supporting surgical intervention as the preferred strategy for appropriate candidates.
- EPN Improves AS Management: Data analysis from DETECT AS presented at New York Valves revealed that electronic provider notifications significantly improve aortic stenosis management, with greater benefits for women. The electronic notifications eliminated gender disparities by increasing female AVR rates from 25.9% to 46.8% within one year, while showing minimal impact on male rates (45.5% vs 49.8%). Women also experienced enhanced survival benefits, specialist referrals, and diagnostic accuracy.
- Please Don’t Stop the RASi: A secondary analysis of the STOP-or-NOT trial demonstrated that preoperative CV risk prediction doesn’t influence patient outcomes when deciding whether to discontinue renin-angiotensin system inhibitors (RASi) before surgery. Using multiple risk assessment tools including RCRI and AUB-HAS2 indices, researchers examined over 2k patients and found no significant difference in postoperative complications or MACE between RASi continuation and discontinuation strategies across all risk categories.
- Supreme Court Upholds Free Screenings, USPSTF: The U.S. Supreme Court issued two key rulings affecting healthcare in a lawsuit filed by Braidwood Management. First, the court denied Braidwood’s challenge to Affordable Care Act provisions requiring insurance companies to fully pay for preventive care services like blood pressure screenings, cholesterol checks, and statins that have been recommended by USPSTF. The court also upheld the constitutionality of the USPSTF, which Braidwood also challenged. The rulings protect patient access to preventive care without requiring cost-sharing.
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Heartflow Plaque Analysis: Accurate CAD Assessment Now Covered Across the US
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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The Benefits of Outsourced Post-Processing
Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.
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Patient Attitudes Towards Us2.ai’s AI-Echo
The medical imaging field is rapidly accepting AI, but how are patients feeling about the shift? Get the scoop on patients’ positive opinions toward Us2.ai’s software that supports task shifting from conventional echo to AI-echo.
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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.
- Vista AI Reduces Patient Backlog: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.
- Precision QRS Detection: QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.
- A Better Way to Coordinate Post-Stroke Care: Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.
- How to Improve Cardiology Workflows and Get More Patient Time: Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.
- 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.
- 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)
- Cloud-Based Enterprise Imaging Empowerment: Do your cardiology imaging workflows follow cloud best practices? Read Optum and Frost & Sullivan’s enterprise imaging whitepaper to help you ensure your team is optimally housing, accessing, analyzing, and leveraging imaging data as the industry shifts to value-based care.
- New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.
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