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Merit WRAPSODY™ Cell-Impermeable Endoprosthesis

Extending Long-Term Vessel Patency in Patients with Obstructions in the Dialysis Outflow Circuit

Dialysis patients can often experience complications due to stenosis and occlusions in the dialysis outflow circuit. This can lead to repeated interventions, frequent trips to the hospital, and inadequate dialysis treatments. The Merit WRAPSODY Cell-Impermeable Endoprosthesis is built to combat these challenges and extend long-term vessel patency rates.

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    Features & Benefits

    UNIQUE TRI-LAYERED CELL-IMPERMEABLE ENDOPROSTHESIS MICROSTRUCTURE

     

    3 key elements of the Merit WRAPSODY Endoprosthesis

    INSIDE NOVEL SPUN GRAFT LAYER

    The innermost layer of the WRAPSODY is made of a biocompatible, novel spun PTFE layer designed to reduce fibrin deposition and thrombus formation without coatings, chemicals, or drugs.

    MIDDLE CELL-IMPERMEABLE GRAFT LAYER

    The WRAPSODY is engineered with an impermeable middle graft layer built to prevent transmural cellular migration without the use of drug bonding.

     

    CASE STUDY

    Dolmatch, et al. JVIR. 2020; 31: 494–502.1 Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model Purpose: To compare the patency, tissue response, and thrombogenicity of the WRAPSODY and a leading ePTFE covered stent.

    CONCLUSION

    The WRAPSODY’s cell-impermeable middle graft layer prevents cellular migration and tissue accumulation (as shown in pink) across device layers and around nitinol stent struts better than the leading ePTFE covered stent.

    Dolmatch Findings - Merit WRAPSODY

    Cross-Sectional Histology Images: Left External Iliac, Animal, 180 days1

     

    OUTER ePTFE STANDARD LAYER

    The outer layer of the WRAPSODY is engineered with a standard, biocompatible ePTFE material that allows for necessary tissue ingrowth to prevent stent migration.

    Close up of the outer ePTFE on the left, and tissue ingrowth on the right

    SOFTENED END ROWS REDUCE EDGE STENOSIS

    WRAPSODY’S end rows are designed with less radial force (1) to better conform to healthy tissue, reduce vessel trauma, and improve long-term patency. Additionally, nitinol struts (2) allow for upsizing of up to 25% for superior vessel conformance

     

    RADIAL STRENGTH AND COMPRESSION RESISTANCE

    Allows the cell-impermeable endoprosthesis to withstand intraluminal forces AND extrinsic pressure placed on the device – and is consistent across all diameter sizes

     

    PINPOINT ACCURACY

    1 – Racheted Deployment Handle
    for one-handed accurate and controlled cell-impermeable stent graft placement

    2 – Single Port
    for flushing guide wire lumen and cell-impermeable stent graft pod

    3 – Safety Clip
    to prevent inadvertent deployment

    4 – Radiopaque Marker Bands
    for enhanced visualisation

    5 – Soft Atraumatic Tip
    for a seamless transition over a 0.035″ guide wire

    HYDROPHILIC COATING

    Allows smooth insertion & withdrawal, along with exceptional trackability

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