This Cardiovascular Video Recap covers major milestones, including first-in-class device approvals, new pharmacologic options, advances in electrophysiology and robotics, and emerging gene and AI-driven approaches. The developments span structural heart disease, cardiomyopathies, arrhythmias, and population health trends, with implications for access and clinical practice.
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:10 First US transseptal TMVR approval – Edwards Sapien M3
0:55 Approval of Myqorzo, aficamten, for obstructive HCM
1:35 Clearance of Stereotaxis Magic robotic ablation catheter
2:02 Acesion Phase 2 trial launch for AP31969 in atrial fibrillation, EU multicentre RCT
2:31 First patient treated with TIMP-3 graft gene therapy in PROTECT during CABG
2:54 First clinical use of YorLabs intracardiac echocardiography system post 510(k)
3:23 JACC analysis of hypertension and diabetes trends in cardiovascular mortality
3:56 ARPA-H ADVOCATE initiative for agentic AI in cardiovascular care
4:22 How to reach us
Transcript
Welcome to the latest edition of Cardiovascular Updates, covering the latest breakthroughs in the field. Brought to you by LucidQuest.
Edwards Lifesciences’ Sapien M3 has received the first US approval for a transseptal transcatheter mitral valve replacement system. Indication, symptomatic moderate to severe or severe mitral regurgitation, including mitral annular calcification with MR or MS, in patients unsuitable for surgery or Teer. The system is fully percutaneous via a transfemoral transseptal approach. In the Encircle single arm pivotal cohort cited by the source, investigators reported MR reduction and symptom gains. Expect this to shape prescriber choice and payer reviews as full data mature.
Cytokinetics has secured US approval for Myqorzo, aficamten, for adults with symptomatic obstructive hypertrophic cardiomyopathy. The Maple HCM study showed improvement in exercise capacity per the source. The Risk Evaluation and Mitigation Strategy allows earlier titration, with echocardiography checks 2 to 8 weeks after a dose change, and maintenance echoes every 6 months. The label and REMS are positioned as more flexible compared with Camzyos in the source summary, which may reduce logistical burden and influence adoption.
Stereotaxis has US clearance for the Magic robotic ablation catheter, indicated for mapping, pacing, and ablation of supraventricular tachycardias in congenital heart disease where manual access is limited. Magnetic navigation is designed to improve precision and stability for complex electrophysiology cases, signaling continued investment in EP robotics.
Acesion Pharma has launched a Phase 2 trial of AP31969 in atrial fibrillation across eight European countries. The design is randomized, double blind, placebo controlled, with 200 patients. This oral SK channel inhibitor targets rhythm control. The primary endpoint is AF burden, measured as time in AF, with continuous monitoring via implantable loop recorders.
In the Protect study, the first patient in the United Kingdom has been treated with a TIMP 3 graft gene therapy during coronary artery bypass surgery. The approach applies a viral vector to saphenous vein grafts ex vivo, aiming to strengthen the grafts and reduce failure. Early recovery is described by the source, outcomes are pending.
YorLabs reports the first clinical use of its intracardiac echocardiography system after 510(k) clearance. The zero CapEx platform provides high resolution 2D ICE, with 4D ICE in development. The initial real world case took place at OHSU during atrial fibrillation ablation under single operator control and integrated with existing workflow.
A JACC linked analysis summarized by the source highlights US trends. Hypertension prevalence was flat from 2009 to 2023, yet hypertension related cardiovascular deaths nearly doubled. Diabetes prevalence and related deaths also increased. These data can inform practice discussions and payer evaluations, while interpretation will depend on study design and control of confounders.
ARPA H has announced Advocate, a program to catalyze patient facing and supervisory agentic AI for cardiovascular care. The goal is an FDA authorized system that integrates wearables and EHR data, supports scheduling, lifestyle guidance, prescription management, diagnostic support, and escalation to clinicians, with a supervisory safety agent.
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Why it matters
- TMVR and EP robotics are expanding treatment options for previously hard-to-treat patients.
- Aficamten’s approval adds competition and potential workflow advantages in oHCM.
- Gene therapy is moving into common surgical adjuncts in CABG.
- US risk factor mortality trends heighten urgency for scalable care models, including agentic AI.
🗓️ Explore details and sources
- Weeks 18 December 2025–7 January 2026
- Week 8–14 January 2026
📚 Find your one-stop page for the full Cardiovascular archive.
FAQ
What is Sapien M3 indicated for in the US?
Symptomatic moderate-to-severe or severe MR, including MAC with MR or MS, in patients unsuitable for surgery or TEER, via a transfemoral transseptal approach [1].
How does Myqorzo’s REMS differ from Camzyos’ per the source?
It allows earlier titration and echo assessments 2–8 weeks after dose changes, with maintenance echoes every 6 months, aiming to reduce logistical burden vs a more rigid algorithm [2].
Who is eligible for the Stereotaxis Magic catheter?
Patients needing EP mapping, pacing, and ablation of supraventricular tachycardias in congenital heart disease where manual access is limited by anatomy or prior surgery [3].
What is Acesion’s primary endpoint in Phase 2?
AF burden, measured as time in AF, with continuous monitoring via implantable loop recorders across eight European countries [4].
What does the PROTECT gene therapy do during CABG?
Applies a TIMP-3 viral vector to saphenous vein grafts ex vivo to reduce remodelling and graft failure risk; first patient treated in the UK [5].
What will ARPA-H’s ADVOCATE agents be designed to do?
Connect to records, schedule care, provide lifestyle guidance, manage prescriptions, support diagnoses, and escalate to clinicians, with a supervisory safety agent and an FDA-authorization goal [8].
Entities / Keywords
Edwards Lifesciences; Sapien M3; transseptal TMVR; MR; MAC; Cytokinetics; Myqorzo; aficamten; Camzyos; REMS; Stereotaxis; Magic catheter; robotic magnetic navigation; Acesion Pharma; AP31969; SK-channel inhibitor; atrial fibrillation; PROTECT; TIMP-3; CABG; YorLabs; ICE; OHSU; JACC; hypertension; diabetes; ARPA-H; ADVOCATE; agentic AI.
References
- https://cardiovascularnews.com/transseptal-tmvr-system-gains-us-fda-approval/
- https://healtheconomics.com/cytokinetics-receives-fda-approval-for-myqorzo-to-compete-in-heart-disease-market/
- https://cardiacrhythmnews.com/stereotaxis-secures-us-fda-approval-for-magic-ablation-catheter/
- https://pharmatimes.com/news/acesion-pharma-launches-phase-2-trial-of-ap31969-in-atrial-fibrillation/
- https://www.progress.org.uk/first-patient-treated-with-gene-therapy-to-improve-heart-bypasses/
- https://cardiovascularnews.com/yorlabss-intracardiac-imaging-system-used-for-first-time-following-us-fda-clearance/
- https://www.aonl.org/node/707959
- https://origin.arpa-h.gov/news-and-events/arpa-h-revolutionize-cardiovascular-disease-management-clinical-agentic-ai