Cardiovascular Today—November, 6 2025

LucidQuest

2 days ago

This week’s cardiology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

In Today’s Newsletter

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🛰️ Terumo OpusWave dual-sensor intravascular imaging cleared by FDA [1] [US • 29 Oct 2025]

https://cardiovascularnews.com/terumo-announces-us-fda-clearance-for-opuswave-imaging-system/
Context: 510(k) clearance for OpusWave with DualView catheter (OFDI plus IVUS), 150 mm pullback, 2.6 Fr profile, 6 Fr guide.
Key point: Terumo received US clearance for its first US intravascular imaging platform that combines OFDI and IVUS in a single catheter.
Implication: Introduces competition that may affect pricing and formulary access.

🩹 CMS finalizes Medicare coverage for renal denervation systems [2] [US • 29 Oct 2025]

https://cardiovascularnews.com/cms-finalizes-coverage-decision-for-renal-denervation-systems/
Context: National Coverage Determination for RF and ultrasound renal denervation in uncontrolled hypertension; Medtronic Symplicity and Recor Paradise previously FDA approved in Nov 2023.
Key point: CMS confirmed Medicare coverage for both modalities, with manufacturers highlighting broader access.
Implication: May expand screening, initiation, and follow-up at scale.

🫀 AtriCure begins BoxX-NoAF IDE trial, first patient treated [3] [US • 30 Oct 2025]

https://cardiovascularnews.com/atricure-announces-treatment-of-first-patient-in-boxx-noaf-clinical-trial/
Context: Prospective, multicenter, randomized IDE trial, up to 960 subjects across up to 75 sites; evaluates EnCompass clamp plus AtriClip LAA exclusion to reduce new-onset AF after cardiac surgery.
Key point: First patient enrolled and treated in BoxX-NoAF; success could support expanded labeling for EnCompass and AtriClip when used together.
Implication: Signals pipeline investment and modality expansion.

🧭 Edwards focuses portfolio on structural heart, post-ESC guidelines [4] [EU • 30 Sep 2025]

https://cardiovascularnews.com/medtech-insights-edwards-bruls-outlines-companys-move-to-specialise-on-structural-heart-disease/
Context: Interview at ESC 2025 on guideline shifts favoring transcatheter therapies and Edwards’ strategic refocus, including acquisitions and CE mark for asymptomatic AS.
Key point: Edwards outlines specialization in structural heart with earlier intervention emphasis, citing guideline support and EARLY TAVR data.
Implication: Signals pipeline investment and modality expansion.

🧪 Repatha Phase 3 VESALIUS-CV met dual primary endpoints, AHA late-breaker planned [5] [US • 31 Oct 2025]

https://www.amgen.com/newsroom/press-releases/2025/10/amgens-landmark-phase-3-repatha-data-to-be-presented-as-late-breaker-at-the-american-heart-association-scientific-sessions-2025
Context: Press release previews AHA 2025 agenda across evolocumab trials and RWE; VESALIUS-CV in high-risk primary-prevention population.
Key point: Amgen states VESALIUS-CV achieved dual primary endpoints reducing MACE in patients without prior MI or stroke; details to be presented.
Implication: May influence prescriber choice and payer reviews pending full data.

🆘 AI ECG improves STEMI triage accuracy in emergency setting [6] [31 Oct 2025]

https://healthcare-in-europe.com/en/news/ecg-ai-stemi-detection-heart-attack-emergency.html
Context: Retrospective real-world evaluation across 3 PCI centers; presented at TCT 2025 and published in JACC: Cardiovascular Interventions.
Key point: AI model detected more true STEMIs and reduced false activations vs standard triage on initial ECG (specific numerators in source).
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🫁 CPR and emergency cardiovascular care guidance updated [7] [US • 31 Oct 2025]

https://www.clinicaladvisor.com/news/guidance-updated-for-cpr-and-emergency-cardiovascular-care/
Context: AHA guideline update in Circulation for adult, pediatric, neonatal life support and systems of care.
Key point: New recommendations include alternating 5 back blows and 5 abdominal thrusts for adult/child choking, updated infant sequence, and a public naloxone algorithm.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

⌚ Smartwatch single-lead ECG AI detects structural heart disease [8] [US • 03 Nov 2025]

https://cardiovascularnews.com/ai-helps-smartwatch-ecg-sensors-to-detect-structural-heart-disease/
Context: Prospective study to be presented at AHA 2025; algorithm trained on >266k 12-lead ECGs, validated externally, then tested in 600 participants using a smartwatch.
Key point: AI achieved high discrimination using smartwatch ECG for multiple structural heart diseases; authors note small disease prevalence and false positives as limits.
Implication: May expand screening, initiation, and follow-up at scale.

🌙 AHA abstract links long-term melatonin use with higher HF risk in insomnia [9] [US • 03 Nov 2025]

Long-term use of melatonin supplements to support sleep may have negative health effects | American Heart Association
Context: TriNetX observational analysis of >130k adults with insomnia using melatonin ≥12 months, compared with matched non-users.
Key point: Long-term melatonin use was associated with higher incident heart failure, HF hospitalization, and all-cause mortality; causality not established.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 Virtue pivotal trial begins, first US patients enrolled [10] [US • 04 Nov 2025]

https://cardiovascularnews.com/virtue-trial-of-sirolimus-eluting-balloon-enrols-first-patients/
Context: IDE pivotal trial comparing Orchestra BioMed’s Virtue sirolimus angio-infusion balloon to Boston Scientific’s Agent paclitaxel-coated balloon; target n=740 across up to 75 US centers.
Key point: Initial cases completed at The Christ Hospital and St Francis; prior pilot showed signals in ISR; Virtue SAB holds FDA breakthrough designations.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Medicare coverage for renal denervation changes near-term access dynamics for treatment-resistant hypertension.
A dual-modality imaging approval introduces a new competitor in US intravascular imaging workflows.
Late-breaking evolocumab outcomes and growing AI-ECG evidence could shift prevention and triage pathways.
Structural heart focus and earlier intervention themes persist across guidelines, trials, and corporate strategy.

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FAQ

What exactly did CMS cover for renal denervation?

Medicare’s finalized NCD allows coverage for both radiofrequency and ultrasound renal denervation in uncontrolled hypertension, aligning with 2023 FDA approvals of Medtronic Symplicity and Recor Paradise [2].

How is Terumo’s OpusWave different from existing IVUS or OCT?

It combines OFDI and IVUS in one catheter with long pullback and small profile, aiming to streamline image-guided PCI with a single device, per company statements [1].

What population is Repatha’s VESALIUS-CV addressing?

High cardiovascular-risk patients without prior MI or stroke, with Amgen reporting dual primary endpoint success to be detailed at AHA 2025 late-breaker [5].

What does AtriCure’s BoxX-NoAF trial test?

Superiority of concomitant surgical ablation box lesion plus LAA exclusion versus no treatment for preventing new-onset AF after cardiac surgery, under an FDA IDE, up to 960 subjects [3].

Are AI ECG tools ready for emergency or wearable screening?

Reports suggest improved STEMI triage performance in ED settings and strong discrimination for structural disease from smartwatch ECG, though both require prospective validation and careful integration [6][8].

Does melatonin increase heart failure risk?

An observational AHA abstract found associations between long-term melatonin use and higher HF events and mortality in chronic insomnia, without proving causality; confounding is possible [9].

Entities / Keywords

Terumo OpusWave, OFDI, IVUS; CMS, renal denervation, Medtronic Symplicity, Recor Paradise; AtriCure, BoxX-NoAF, EnCompass, AtriClip, POAF; Edwards Lifesciences, TAVI, Pascal, Evoque; Amgen, evolocumab, Repatha, VESALIUS-CV, RWE; AI-ECG, STEMI triage, JACC, TCT; AHA CPR guidance; smartwatch ECG, structural heart disease; Orchestra BioMed, Virtue SAB, Agent DCB, ISR.