Cardiovascular Today—January 29, 2026

This is a weekly update in cardiovascular medicine, covering regulatory decisions, late-stage clinical data, AI-enabled diagnostics, major trials, and strategic investments. Themes include device approvals, prevention-focused outcomes, and expanded indications across heart failure and structural heart disease.

In Today’s Newsletter

Dive deeper

🔌 Abbott wins CE mark for dual-energy AF ablation catheter [1] [EU • 20 Jan 2026]

https://cardiovascularbusiness.com/topics/clinical/heart-rhythm/abbott-secures-key-approval-new-catheter-capable-pfa-radiofrequency-ablation
Context: TactiFlex Duo Ablation Catheter, Sensor Enabled; FOCALFLEX CE mark study supported safety and effectiveness; FLEXPULSE IDE underway.
Key point: First CE-marked catheter in Abbott’s portfolio that can deliver both PFA and RF, allowing intra-procedure switching.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Medtronic invests US$90m in Anteris for DurAVR TAVI program [2] [23 Jan 2026]

https://cardiovascularnews.com/medtronic-invests-in-anteris-technologies-maker-of-duravr-system/
Context: Funds to support pivotal PARADIGM RCT and commercialization; IDE approval granted Nov 2025.
Key point: Strategic financing backs a balloon-expandable, single-piece TAVI designed to mimic native valve geometry.
Implication: Signals pipeline investment and modality expansion.

🫀 HighLife TMVR system receives CE mark for severe MR [3] [EU • 26 Jan 2026]

https://cardiovascularnews.com/highlife-tmvr-system-gains-ce-mark/
Context: Transfemoral, dual-component valve-in-ring; annulus sizes 30–53 mm; early experience reports durable MR reduction with no LVOTO or PVL.
Key point: Approved for patients unsuitable for surgery or TEER, with phased rollout and post-market follow-up.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Evolocumab lowers MACE in high-risk patients without prior events [4] [26 Jan 2026]

https://cardiovascularnews.com/evolocumab-cuts-mace-risk-even-in-patients-with-no-prior-events/
Context: VESALIUS-CV, >12,000 pts, median 4.6 years; dual primary composites reduced; presented at AHA 2025 and NEJM publication.
Key point: Reported 25% reduction in CHD death/MI/ischemic stroke and 19% reduction including revascularization vs placebo on intensive background therapy.
Implication: May influence prescriber choice and payer reviews pending full data.

🤖 AI flags valve disease and ventricular dysfunction from single-view echo [5] [26 Jan 2026]

https://cardiovascularnews.com/study-validates-ai-tools-ability-to-detect-valvular-disease-and-ventricular-dysfunction/
Context: Frontiers in Digital Health study; trained on >120k echoes; validated prospectively.
Key point: Model achieved AUC up to 0.97 for reduced EF and 0.95 for RV dysfunction using 2D grayscale clips alone.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🏥 PUMA trial to test PAC vs CVC in cardiac surgery, co-designed with patients [6] [AU • 27 Jan 2026]

https://monashhealth.org/news/patients-co-design-world-first-clinical-trial-to-determine-if-invasive-heart-surgery-monitoring-helps-or-harms-patients/
Context: MRFF grant $3.7m; 2,000-patient, multicentre RCT; low-risk cardiac surgery; start in 2026.
Key point: Compares invasive PAC with less-invasive CVC to assess outcomes, resource use, and environmental footprint.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 Sex hormones and CV risk in type 2 diabetes, Johns Hopkins study [7] [US • 27 Jan 2026]

https://www.news-medical.net/news/20260127/A-New-Johns-Hopkins-Medicine-Study-Suggests-That-Certain-Sex-Hormones-Could-Play-An-Important-Role-In-Understanding-Long-Term-Heart-Health-e28094-Especiall.aspx
Context: Diabetes Care publication; Look AHEAD cohort samples at baseline and 1 year.
Key point: In men, higher baseline testosterone linked to lower risk, and increases in estradiol linked to higher risk; no meaningful links reported in women (endpoint not specified).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

⚡ CVRx starts BENEFIT-HF to expand Barostim indication [8] [US/DE • 26 Jan 2026]

https://cardiovascularnews.com/cvrx-announces-initiation-of-benefit-hf-trial-of-barostim-device-in-significantly-expanded-population/
Context: 2,500 pts, ~150 centers in USA and Germany; CMS Category B IDE coverage; primary composite of all-cause mortality and HF decompensation.
Key point: Tests Barostim in symptomatic HF with LVEF <50% and NT-proBNP <5,000 pg/mL, beyond current label.
Implication: May influence prescriber choice and payer reviews pending full data.

🧯 Asundexian Phase 3 OCEANIC-STROKE results slated for ISC 2026 [9] [EU • 27 Jan 2026]

https://www.bayer.com/en/us/news-stories/asundexian-in-secondary-stroke-prevention
Context: Factor XIa inhibitor; >12,300 pts; Bayer says primary efficacy and safety endpoints met in Nov 2025; first full presentations Feb 4–6 in New Orleans.
Key point: Main results and prespecified subgroup analysis to be presented in late-breaking sessions.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Dual-modality ablation and new TMVR options broaden structural and EP toolkits in Europe.
Evolocumab’s prevention signal in patients without prior events may shift LDL-lowering strategies earlier.
AI-enabled single-view echo could decentralize cardiac screening and triage.
Neuromodulation and TAVI investments point to continued device-driven innovation in HF and valve disease.
Factor XIa inhibition, if confirmed, could reshape secondary stroke prevention beyond current anticoagulants.

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of services. Discover how we can help you.

📚 See the full Cardiovascular archive on our research hub page

FAQ

What is Abbott’s TactiFlex Duo and why is CE mark notable?

A catheter that delivers both PFA and RF for AF ablation, allowing intra-procedure switching. CE mark enables European use while a U.S. IDE trial proceeds [1].

How is Medtronic involved with Anteris and DurAVR?

Medtronic invested US$90m to support the PARADIGM pivotal RCT and commercialization of the single-piece DurAVR TAVI system [2].

Who is eligible under HighLife’s TMVR approval?

Adults with symptomatic moderate-severe or severe MR deemed unsuitable for surgery or TEER, via a transfemoral valve-in-ring system [3].

What did VESALIUS-CV show for evolocumab?

In >12,000 high-risk patients without prior MI or stroke, evolocumab reduced primary MACE composites versus placebo on intensive background therapy [4].

What exactly did AISAP’s AI achieve?

Prospective validation showed high AUC for detecting reduced EF and RV dysfunction using single-view 2D grayscale echo clips [5].

How will BENEFIT-HF expand Barostim use if positive?

It assesses patients with LVEF <50% and higher NT-proBNP threshold, with a primary composite of mortality and HF decompensation, potentially tripling the indicated population [8].

Entities / Keywords

Abbott; TactiFlex Duo; pulsed field ablation; radiofrequency ablation; Medtronic; Anteris Technologies; DurAVR; PARADIGM; HighLife; TMVR; mitral regurgitation; Evolocumab; Repatha; VESALIUS-CV; AISAP; echocardiography AI; Monash University; PUMA trial; pulmonary artery catheter; central venous catheter; CVRx; Barostim; BENEFIT-HF; Bayer; Asundexian; OCEANIC-STROKE; Factor XIa inhibitor.