Watch Our Video Summary Capturing Top Cardiovascular News from the Last Two Weeks
From the EU’s coordinated Cardiovascular Health Plan, first-in-human smart-heart implant, to Repatha’s primary-prevention success in VESALIUS-CV—this episode’s signals are powerful. We span policy and prevention, cardiovascular devices, genome editing, and lipid and antihypertensive therapies, with pivotal trial results and regulatory clearances across heart health, underscoring guideline-driven innovation and patient-centered outcomes.
Top Stories Covered in This Video
🇪🇺 EU moves on coordinated Cardiovascular Health Plan and risk-factor policy 📜 [1] [EU • 26 Sep 2025]
Context: Medscape reports on ESC perspectives and EU actions, including JACARDI, tighter air-quality limits, heat-health plans, and nicotine product regulation.
Key point: EU is building a Cardiovascular Health Plan spanning prevention, detection, data use, equity, and environmental policies.
Implication: Could inform practice and payer discussions; interpretation depends on policy design and implementation.
🫀 First-in-human “smart heart” transcatheter implant for HF congestion 📡 [2] [30 Sep 2025]
https://www.massdevice.com/relief-cardiovascular-first-human-smart-heart-implant/
Context: Relief Cardiovascular implanted a pressure-guided active valve in the vena cava in Georgia within a feasibility study; nightly cloud sync reported.
Key point: Device integrates hemodynamic monitoring with adaptive therapy to reduce preload and improve renal vein flow for diuretic-resistant HF.
Implication: Signals pipeline investment and modality expansion.
🧬 CityUHK secures support to advance “DNA surgery” editors to clinic (liver/CV) 🧪 [3] [30 Sep 2025]
https://www.eurekalert.org/news-releases/1100246
Context: CityUHK team to develop two genome-editing therapeutics, leveraging high-fidelity nucleases and eLNP delivery for somatic DNA correction.
Key point: Program targets liver and cardiovascular genetic diseases with IND-enabling work and investigator-initiated trials planned.
Implication: Signals pipeline investment and modality expansion.
💊 Oral semaglutide lowers MACE and MALE in T2D regardless of PAD status 🦵 [4] [01 Oct 2025]
Context: SOUL CVOT subanalysis presented at EASD 2025; 9,650 adults with T2D and CV or CKD; prespecified PAD subgroup examined.
Key point: Similar directional benefit on MACE with or without PAD, with greatest effect in non-PAD; MALE reduced vs placebo; statistical caveats noted.
Implication: May influence prescriber choice and payer reviews pending full data.
🧷 Taho files FDA NDA for apixaban oral-dissolving film (TAH3311) 💊 [5] [US • 01 Oct 2025]
Context: TDS-platform ODF formulation aims to aid stroke survivors, elderly, and others with dysphagia; partnerships sought.
Key point: NDA submitted for apixaban ODF to improve convenience and adherence while reducing aspiration risk.
Implication: May expand screening, initiation, and follow-up at scale.
🧬 Repatha shows primary-prevention event reduction in VESALIUS-CV 🧠 [6] [US • 02 Oct 2025]
Context: >12,000 high-risk adults without prior MI or stroke, median follow-up ~4.5 years; dual primary endpoints met, no new safety signals; AHA Nov presentation planned.
Key point: Evolocumab added to standard LDL-C therapy significantly reduced MACE vs standard therapy alone in primary prevention.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 FDA OKs first-in-human for UCLA’s ENPP1 antibody AD-NP1 🔬 [7] [US • 06 Oct 2025]
Context: Academic, publicly funded program targeting ENPP1 to boost repair in post-injury heart and other organs; preclinical efficacy in mice and monkeys reported.
Key point: FDA cleared initiation of human trials for monoclonal antibody AD-NP1 to enhance tissue repair by modulating energy pathways.
Implication: Signals pipeline investment and modality expansion.
📉 Baxdrostat hits Phase III Bax24 primary endpoint in resistant HTN ⏱️ [8] [07 Oct 2025]
Context: Randomised, double-blind, placebo-controlled, 12-week trial of 2 mg QD on top of standard care; safety consistent with BaxHTN; AHA late-breaker planned.
Key point: Statistically significant, clinically meaningful reduction in 24-hour ambulatory SBP vs placebo, including morning hours.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- EU policy could scale prevention via clean air, heat-health, and nicotine controls tied to CV outcomes.
- Device-driven congestion therapy hints at a new class of data-guided HF implants.
- GLP-1 benefits in limb outcomes may broaden cardio-renal-metabolic utility.
- Primary prevention PCSK9 data may expand lipid-lowering earlier in the risk continuum.
- A first-in-class aldosterone synthase inhibitor addresses resistant hypertension where control is poor.
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FAQ
What is the EU Cardiovascular Health Plan aiming to change?
A coordinated strategy spanning prevention, early detection, improved care pathways, data use, equity, and environmental risk reduction, alongside JACARDI implementation across member states [1].
How does Relief Cardiovascular’s implant work in HF?
It is a pressure-guided active valve in the vena cava that monitors hemodynamics and delivers adaptive decongestion therapy, targeting diuretic-resistant patients; first-in-human implants completed in a feasibility study [2].
Does oral semaglutide help patients with PAD?
In SOUL subanalysis, benefits on CV outcomes appeared similar regardless of PAD status, with greatest effect in non-PAD, and MALE were reduced vs placebo, though statistical limitations were noted [4].
What is Taho’s TAH3311 meant to solve?
An apixaban oral-dissolving film intended to improve adherence and reduce aspiration risk in patients with swallowing difficulties; NDA submitted to FDA [5].
What is new about Repatha’s VESALIUS-CV result?
It is a primary-prevention setting where evolocumab reduced MACE vs standard therapy alone, with no new safety signals and full results pending at AHA 2025 [6].
What did Bax24 show for baxdrostat?
A once-daily 2 mg regimen delivered a significant and clinically meaningful reduction in 24-hour ambulatory SBP versus placebo in resistant hypertension, with consistent safety vs prior studies [8].
Entities / Keywords
European Union: Cardiovascular Health Plan, JACARDI, air-quality directive, nicotine regulation.
Relief Cardiovascular: transcatheter smart implant, preload reduction, renal vein flow.
CityUHK: DNA surgery, high-fidelity nucleases, eLNP delivery.
Novo Nordisk: oral semaglutide, SOUL, PAD, MALE.
Taho Pharmaceuticals: TAH3311, apixaban ODF, TDS platform.
Amgen: Repatha, evolocumab, VESALIUS-CV, PCSK9.
UCLA: AD-NP1, ENPP1, tissue regeneration.
AstraZeneca: baxdrostat, Bax24, aldosterone synthase, resistant hypertension.
References
https://www.massdevice.com/relief-cardiovascular-first-human-smart-heart-implant/