This biweekly Cardiovascular Video Recap covers late-stage clinical data, guideline updates, regulatory milestones, device evaluations, and access initiatives, offering a concise look at developments across care pathways.
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:08 Milestone Pharmaceuticals Cardamyst nasal spray set for mid-Feb U.S. launch for adult PSVT after FDA approval
0:39 Allegheny Health Network opens Pennsylvania’s first South Asian Heart Clinic focused on prevention and culturally tailored risk management
1:04 AngioDynamics convenes Cardiovascular Scientific Forum, highlights IDE trials and modified AlphaVac F1885 510(k) progress
1:37 Bayer asundexian reduces recurrent stroke in OCEANIC-STROKE without increased major bleeding
2:04 American Heart Association and American Stroke Association update early AIS guideline, broaden thrombolysis and EVT access
2:37 Abbott Amulet 360 shows high early LAA closure and favorable safety in VERITAS
3:07 P&F Products and Features TricValve gains EU MDR certification, enabling EU availability and supporting U.S. TRICAV II IDE
3:28 Brainomix adds automated net water uptake to Brainomix 360 stroke AI platform
3:56 How to reach us
Transcript
Welcome to the latest edition of Cardiovascular Updates, covering the latest breakthroughs. Brought to you by LucidQuest.
Milestone Pharmaceuticals signaled mid-February U.S. commercialization of etripamil, brand name Cardamyst, a home-use nasal spray for acute conversion of paroxysmal supraventricular tachycardia in adults following FDA approval in December 2025, with payer engagement and copay support planned. This could shift some PSVT episodes from the emergency department to at-home care, depending on access and coverage.
Allegheny Health Network opened Pennsylvania’s first South Asian Heart Clinic, a prevention-focused program offering advanced biomarkers including Lp(a) and ApoB, genetics, coronary calcium scoring, metabolic assessment, and culturally specific counseling, with collaboration across cardiology and endocrinology
AngioDynamics convened a Cardiovascular Scientific Forum in Fort Lauderdale, underscoring evidence generation and reimbursement planning across venous thromboembolism, blood management, and structural infection, with IDEs active for Apex-Return in intermediate-risk pulmonary embolism and Pave in right-sided infective endocarditis, plus a modified AlphaVac F1885 with expanded 510(k) clearance
Bayer reported that in Oceanic-Stroke, a Phase 3 trial of more than 12,300 patients with non-cardioembolic ischemic stroke or high-risk TIA on antiplatelets, asundexian 50 mg reduced recurrent stroke without increasing major bleeding, with full data presented at the International Stroke Conference and U.S. fast-track designation for secondary prevention
The AHA and ASA issued an updated early acute ischemic stroke guideline, replacing 2018 recommendations, endorsing alteplase or tenecteplase within 4.5 hours for eligible disabling deficits without advanced imaging selection, expanding endovascular therapy, including basilar artery occlusion within 24 hours when NIHSS is 10 or higher, and adding pediatric and mobile stroke unit guidance
Abbott reported early Veritas data for the Amulet 360 left atrial appendage occlusion system, with 93.9 percent complete closure at 45 days, high implant success, and low early complications across 400 patients at 34 sites in the U.S., Canada, and Europe, with results presented at the AF Symposium and published in JACC: EP
The TricValve bicaval valve system received EU MDR Class III certification for severe tricuspid regurgitation with caval reflux, supporting EU availability and international expansion, while the U.S. TRICAV II pivotal remains authorized under an IDE from December 2025
Brainomix introduced next-generation stroke AI at the International Stroke Conference in New Orleans, adding automated net water uptake from non-contrast CT to the Brainomix 360 platform alongside ischemic core and e-Aspects, with regulatory-cleared NWU output intended to support early injury assessment and transfer decisions, and multiple abstracts highlighted
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Why it matters
- Factor XIa inhibition could reshape secondary stroke prevention if bleeding remains low in practice [4].
- Streamlined AIS pathways and EVT guidance can expand treatment capacity across hospitals [5].
- Home-use PSVT therapy may divert episodes from ERs if access and coverage align [1].
- MDR compliance favors devices with robust clinical and post-market systems [7].
- AI imaging that quantifies early ischemic injury may aid triage and transfer decisions in stroke networks [8].
🗓️ Explore details and sources
- Weeks 29 January – 4 Febuary 2026
- Week 5–11 February 2026
📚 Find your one-stop page for the full Cardiovascular archive.
FAQ
When will Cardamyst be available and for whom?
Milestone targets mid-February 2026 U.S. commercialization for adult PSVT episodes after FDA approval in Dec 2025. Patient support and payer engagement are planned [1].
What services will AHN’s South Asian Heart Clinic provide?
Advanced biomarkers including Lp(a) and ApoB, genetics, calcium scoring, metabolic assessment, culturally specific nutrition counseling, endocrinology collaboration, and outcomes tracking [2].
Which AngioDynamics trials are active under IDEs?
APEX-Return for AlphaReturn with AlphaVac MMA in intermediate-risk PE and PAVE for AngioVac in right-sided infective endocarditis, plus a modified AlphaVac F1885 with expanded 510(k) clearance [3].
What did OCEANIC-STROKE report for asundexian?
A reduction in recurrent stroke versus placebo without an increase in major bleeding in non-cardioembolic stroke or high-risk TIA on antiplatelets. Full data were presented at ISC [4].
What are the headline updates in the new AIS guideline?
Alteplase or tenecteplase within 4.5 hours for disabling deficits without advanced imaging selection, broader EVT indications including basilar artery occlusion within 24 hours, plus pediatric recommendations [5].
What early outcomes did Abbott report for Amulet 360?
In VERITAS, 93.9% achieved complete LAA closure at 45 days with high implant success and low early complications reported [6].
What is TricValve’s regulatory status?
EU MDR CE certified for severe TR with caval reflux and investigational in the U.S., with TRICAV II pivotal authorized in Dec 2025 under IDE [7].
What is Brainomix’s new capability and where was it introduced?
Automated net water uptake on NCCT within Brainomix 360 Next Generation, introduced at the International Stroke Conference in New Orleans, with multiple abstracts highlighted [8].
Entities / Keywords
Milestone Pharmaceuticals; etripamil; Cardamyst; PSVT • Allegheny Health Network; South Asian Heart Clinic • AngioDynamics; AlphaVac; AlphaReturn; AngioVac; APEX-Return; PAVE • Bayer; asundexian; OCEANIC-STROKE; Factor XIa • AHA; ASA; AIS guideline; EVT; tenecteplase; alteplase • Abbott; Amulet 360; VERITAS; LAA occlusion • P&F Products and Features; TricValve; EU MDR; TRICAV II • Brainomix; Brainomix 360; net water uptake; NCCT; ISC.
References
https://pharmaphorum.com/news/bayer-reveals-data-behind-asundexians-stroke-win
https://abbott.mediaroom.com/press-releases?item=124733
https://cardiovascularnews.com/tricvalve-bicaval-valve-system-gains-eu-mdr-certification/