The Stena Aortic Multi-Layer Flow Modulator is an advanced, self-expandable endovascular device engineered to promote controlled blood flow and aortic remodeling in a variety of aortic pathologies. Designed with a multi-layer tubular mesh structure, this stent optimizes laminar flow while providing robust radial support, conformability, and enhanced safety for complex aortic anatomies.
Multi-Layer Tubular Mesh
- Five-Layer Design: The stent is meticulously knitted from a superalloy biomedical wire, forming five distinct layers that distribute wall stress and maintain a stable configuration.
- Flow-Mediated Healing: The mesh’s micro-porosity fosters effective laminar flow within the aorta, supporting progressive thrombosis of the aneurysm sac in aneurysmal disease and enhanced remodeling in dissection scenarios.
Superalloy Wire Construction
- Biocompatibility and Durability: The wire alloy is carefully selected for its high corrosion resistance, fatigue strength, and excellent conformability.
- Self-Expanding Mechanism: Once deployed, the stent exerts controlled radial force to ensure secure apposition against the aortic wall, minimizing the risk of device migration.
Radiopaque Tantalum Markers
- Precise Fluoroscopic Visualization: Tantalum markers at both ends facilitate accurate placement under imaging guidance, ensuring correct proximal and distal landing zones.
- Enhanced Safety: Intraoperative and follow-up imaging are streamlined, enabling clinicians to verify device expansion and position over time.
Flexible Delivery and Locking System
- Sheath Lock Mechanism: The integrated sheath lock prevents premature stent deployment, providing operators with predictable and controlled release.
- Hemostasis Valve: A specialized valve setup ensures minimal blood loss and stable guidewire management throughout the procedure.
Clinical Evidence
The Stena Multilayer Flow Modulator has been the subject of peer-reviewed clinical reports in aortic aneurysm repair:
- Preliminary clinical experience in 12 patients (Cirugia y Cirujanos, 2025) — technical success was 100% with complete aneurysm sac thrombosis in all patients at 6 months, preserved branch-vessel patency, and no rupture, migration, retraction, or fracture. DOI: 10.24875/CIRUE.M25000885
- Role of multilayer flow modulator stents in arterial aneurysms (Therapeutic Advances in Cardiovascular Disease, 2024) — narrative review of the hemodynamic rationale and published outcomes of multilayer flow modulation, including branch-preserving repair where conventional stent grafts are limited. DOI: 10.1177/17539447241283736
Browse the full INVAMED Clinical Evidence Library for source-linked study data.
