Catheter-Directed & Mechanical Thrombectomy Innovations

1. AlphaVac F18 Mechanical Aspiration System

  • The APEX‑AV trial, evaluating a mechanical aspiration thrombectomy device (AlphaVac F18; AngioDynamics) in intermediate‑risk PE, showed meaningful reductions in right ventricle-to-left ventricle (RV/LV) ratio (~29%) and clot burden (~35.5%) at 48 hours, with acceptable safety profiles. This device received FDA 510(k) clearance for PE in April 2024.HealioThe Wall Street JournalMedscape

2. Hēlo PE (ENGULF Trial)

  • The ENGULF trial tested a novel thrombectomy system featuring an expandable funnel and internal agitator for clot disruption. It achieved a 23.2% mean reduction in RV/LV ratio at 48 hours post-procedure, with no major adverse events or deaths at 30 days.HealioEurekAlert!SCAI

3. FlowTriever Device – FLASH & FLAME Studies

  • FLASH registry and the FLAME study are evaluating the FlowTriever device in high- and intermediate-risk PE. Early findings show very low in-hospital mortality (~1.9%), compared to 29.5% in standard therapy cohorts.Lippincott Journals

Ultrasound-Enhanced Thrombolysis (USCDT)

  • A robust real-world analysis (REAL‑PE) comparing ultrasound-assisted catheter-directed thrombolysis (USCDT) with mechanical thrombectomy (MT) found that USCDT had lower rates of major bleeding and hemoglobin reduction, although in-hospital mortality and length of stay were similar between the two.EurekAlert!
  • Meta-analyses and studies suggest USCDT may better improve cardiopulmonary parameters and reduce bleeding risk compared to systemic thrombolysis.WikipediaEurekAlert!

Bashir Endovascular Catheter (BEC)

  • The Bashir catheter (Thrombolex) uses an expandable basket design for enhanced drug delivery into clots. In the RESCUE trial:
    • RV/LV ratio dropped by 33%
    • Clot burden reduced by 35.9%
    • Major bleeding rate was <1%
    • Average hospital stay: 2.8 days
  • This device received FDA clearance in April 2023.PMC

Emerging Mechanical Thrombectomy Techniques

Milli-Spinner Thrombectomy

  • A novel approach involving a “milli‑spinner” technology that densifies fibrin networks mechanically and ejects red blood cells—resulting in up to 90% clot volume reduction in in-vitro and in-vivo models. This method targets clot structure rather than fragmenting it, potentially reducing distal embolism risk and improving efficacy.arXiv

Digital & AI-Enhanced Support

  • Although not an intervention per se, new AI-driven models may advance patient management. For example, PEP‑Net, combining 3D ResNet and XGBoost, achieved ~94–94.5% accuracy in predicting 30-day in-hospital mortality based solely on initial CT scans.arXiv
  • Additionally, large language models (LLMs) are being evaluated for automating extraction of PE-related data from radiology reports, offering potential to streamline registry data handling.arXiv

Summary Table

Innovation Highlights
AlphaVac F18 FDA-cleared mechanical aspiration, 29% RV/LV reduction
Hēlo PE (ENGULF) Expandable funnel device, safe with 23% RV/LV improvement
FlowTriever (FLASH/FLAME) Very low mortality (~1.9%) in high-risk PE
USCDT (Ultrasound-assisted) Fewer bleeding complications, effective thrombolysis
Bashir Catheter (BEC) Basket delivery with low bleeding, short hospital stay
Milli‑spinner Thrombectomy High-volume clot reduction via microstructural disruption
AI Tools (PEP‑Net, LLMs) Enhanced prognosis prediction and data abstraction automation

Bottom Line

There’s a noticeable shift toward minimally invasive, catheter-based mechanical and pharmacomechanical strategies for PE that offer improved efficacy, safety, and quicker recovery. Devices like AlphaVac, Hēlo, FlowTriever, Bashir BEC, and the emerging milli-spinner show particular promise. Ultrasound-assisted thrombolysis continues to hold therapeutic appeal due to lower bleeding risks. Meanwhile, AI tools are emerging to support decision-making and institutional data handling.