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TAVR in 2025, FTC vs. Edwards, and Pregablin HF Link
August 11, 2025
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Together with
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“Heart attacks are no longer the number one cause of death. The power of modern medicine. The advances in the past 20 years have been jaw dropping. I still think TAVR is borderline sorcery. Astonishing advances and some spectacular failures…this is how science advances.”
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Ryan P. Daly, MD
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2025 has been a year of many cardiology trends, with one stand out technology capturing much of the spotlight – transcatheter aortic valves. To keep our valves in a row, Cardiac Wire has compiled a breakdown of the top TAVR makers, movers, shakers, and potential future players.
Starting off with the biggest player, Edwards Lifesciences controls about 60-70% of the U.S. TAVR market and has some of the most proven tech in the segment…
- Edwards markets the balloon-expandable SAPIEN platform, which is the longest‑established TAVR system (FDA-approved since 2011).
- Earlier this year, the FDA approved SAPIEN’s use for lower-risk and asymptomatic patients thanks to positive results from the EARLY TAVR trial.
- Shoring up its TAVR pipeline for AR therapy, Edwards also acquired JenaValve and JC Medical in 2024 (although the FTC is now trying to block JenaValve).
Medtronic isn’t far behind and essentially makes up the remainder of the market, with 30-35% of TAVR procedures worldwide using a Medtronic valve.
- The company’s product line includes the CoreValve / Evolut series (self‑expanding nitinol valves).
- Some studies, like SMART, suggest Medtronic’s valves could lead to better outcomes in patients with smaller aortic annuli.
Abbott doesn’t intend to let TAVR stay a two horse race for long, and is working on gaining regulatory approval for its own devices.
- Abbott currently produces the Navitor TAVR system (successor to its older Portico), which is in active clinical trials including the ENVISION pivotal study.
Boston Scientific was a TAVR player up until earlier this year when it quietly discontinued its Acurate product line due to unfavorable trial results and potential stroke risks.
So who is left to challenge Edwards and Medtronic for the TAVR throne?
- Anteris Technologies – Anteris’ balloon-expandable DurAVR THV system looks and works like a human valve (all other TAVRs have three fixed leaflets), and claims calcification benefits.
- JenaValve Technology – Originally Chinese but facing acquisition from Edwards, the JenaValve Trilogy system is undergoing FDA trials for aortic regurgitation and might allow more complex aortic access methods.
- JC Medical – Now also owned by Edwards outside of China, the J‑Valve system is used for both AS/regurgitation and has multiple trials underway.
- Meril Life Sciences – Developer of the Myval TAVR system, India’s first homegrown THV, which launched commercially in India and was CE‑marked in 2019.
The Takeaway
TAVR is certainly here to stay, and while it’s been dominated by two companies for most of its short history, the competition could just be getting started.
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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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Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF
Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.
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- Edwards’ TAVR-AR Problem: The FTC just voted 3-0 to block Edwards Lifesciences’ $945M acquisition of JenaValve, arguing that it would wipe out competition if Edwards owned the two most advanced TAVR devices for aortic regurgitation. Edwards made a power move into the TAVR-AR space last summer, acquiring the only two TAVR developers with ongoing U.S.-based AR trials (JenaValve and JC Medical). However, the FTC says the deals would stifle innovation, limit patient access, and raise prices, claims that Edwards and JenaValve plan to fight in court.
- Semaglutide’s Cost-Benefit Disconnect: A JAMA study of 23,500+ adults showed that semaglutide (Ozempic/Wegovy) drives weight and cardiometabolic improvements, but might still lead to higher healthcare spending (even if you exclude the GLP-1’s costs). The study’s semaglutide population shed ~4% of their weight over their 13th to 24th months of treatment, while lowering their blood pressure, cholesterol, and A1c. However, the semaglutide users still had ~$80 higher monthly healthcare costs, calling into question previous claims that GLP-1s “will pay for themselves” by reducing downstream healthcare costs.
- DCB NTAP: Boston Scientific scored a big Medicare win for its AGENT drug-coated balloon, used to treat coronary in-stent restenosis. CMS granted the AGENT DCB a New Technology Add-on Payment, giving hospitals extra reimbursement for eligible inpatient cases starting in October, and joining an outpatient Transitional Pass-Through payment that was effective January 1, 2025. The AGENT DCB gained FDA approval last year, after over 100k treatments internationally, and the new reimbursements should help drive U.S. adoption.
- Pregabalin’s HF Risks: A new Medicare study suggests older adults taking pregabalin for chronic pain treatment could face higher HF risks than those taking gabapentin. The 246k patient study found that pregabalin users had more HF hospitalizations and emergency visits (18.2 vs 12.5 per 1,000 person-years) and that HF risk was particularly elevated in those with CVD history. Researchers now urge careful CV assessment before prescribing pregabalin to older patients, noting that even small absolute risk increases create healthcare burdens.
- Heartflow Shares Jump 50% in IPO: Shares of cardiac AI company Heartflow jumped 50% on August 8, the first day of trading following the company’s IPO. Heartflow raised $317M by issuing 16.7M shares at $19 each, up sharply from the $215M estimated the week before the IPO. That would provide a significant cash infusion for a company that’s already raised a stunning amount of capital (estimated $927M before now), and it might represent the first U.S. IPO from a cardiac imaging AI startup.
- Orchestra Adds $70M: Orchestra BioMed raised $70M from Ligand Pharmaceuticals ($40M) and Medtronic ($30M) to advance its AVIM therapy for hypertension and Virtue SAB therapy for coronary artery disease. Ligand will receive royalties from Orchestra’s future AVIM and Virtue SAB sales, while Medtronic’s funding expands their partnership to develop AVIM-enabled leadless pacemakers. The funding follows solid progress, as Orchestra’s Virtue balloon just landed FDA IDE for U.S. pivotal trials, while AVIM therapy has shown positive trial results and just gained FDA Breakthrough Designation.
- Sanofi Buys Plozasiran Rights in China: Sanofi will pay $130M upfront and up to $265M in regulatory milestones to acquire rights to plozasiran in China from Arrowhead Pharmaceuticals’ Visirna Therapeutics subsidiary. Plozasiran is an investigational RNAi therapeutic for elevated triglycerides and familial chylomicronemia syndrome and has already received Breakthrough Therapy and Priority Review designations from China’s NPMA.
- Radella’s MD-18 Success: Radella Pharmaceuticals announced positive Phase 1b results for its obesity and diabetes treatment, MD-18. The drug was tested in 36 healthy volunteers over 28 days, and achieved 2.7% weight loss with muscle mass preservation, unlike some GLP-1 drugs that cause muscle loss. MD-18 works as a dual-mechanism peptide that targets the PTP1B gene to restore leptin signaling and increase energy expenditure. Encouragingly, the study’s results showed improved cholesterol, insulin sensitivity, and liver markers with minimal side effects.
- Siesta Now, AFib Later? Siestas are a central part of Iberian and even Mediterranean culture, but this centuries old tradition could lead to increased AFib risk. A 15-year study of 21k Spanish university graduates found that long daytime naps (≥30 minutes) increased AFib risk by 62%, while inadequate nighttime sleep (<6 or >8 hours) increased risk by 89% compared to optimal sleep patterns. Participants with both long naps and inadequate nighttime sleep combined ultimately had a threefold higher AFib risk.
- InfoBionic.Ai ECG Patch 510(k): InfoBionic.Ai announced the FDA clearance of its MoMe ARC 1-Lead Patch, a disposable, single-lead add-on to its AI-powered remote cardiac monitoring platform. The lightweight patch enables extended ECG monitoring without hardware swaps or workflow changes, with the goals of streamlining setup for clinicians and boosting comfort and adherence for patients. The MoMe ARC 1-Lead Patch joins InfoBionic.Ai’s original 6-lead configuration, giving the company two distinct ECG options to “meet patients where they are.”
- RPM for Hypertension Control: JACC: Advances published a large study on over 23k Cadence users with hypertension, which found that the startup’s remote patient monitoring services led to significant improvements in blood pressure control. By leveraging Cadence’s smart BP cuff and tech-enabled protocols, clinicians were able to drive a 14/8 mm Hg average reduction in BP over 30 weeks. That represents a 70% relative increase in the number of patients at goal BP at follow-up.
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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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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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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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- Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.
- 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.
- 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.
- 5,600 Ways to Improve Your Cardiac Ultrasound Workflow:AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.
- 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.
- 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)
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