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WRAPSODY Cell-Impermeable Endoprosthesis (CIE)

Designed to Maintain Long-Term Vessel Patency in Patients with Obstructions in the Dialysis Outflow Circuit

Hemodialysis 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. WRAPSODY® CIE is built to combat these challenges and maintain long-term vessel patency rates.

Indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the dialysis access outflow circuit, including stenosis or occlusion;
• in the peripheral veins of individuals with an arteriovenous (AV) fistula,
• at the venous anastomosis of a synthetic AV graft.

For safety information, contraindications, and warnings, please access the IFU.

Please Note: The product described on this page is for sale and use in the United States only. You can find the European-approved Merit WRAPSODY here.

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    Features & Benefits

    Innovative Covering with Tri-Layered Microstructure Designed to Maintain Long-Term Vessel Patency

    Merit WRAPSODY™ Cell-Impermeable Endoprosthesis- UNIQUE TRI-LAYERED CELL-IMPERMEABLE ENDOPROSTHESIS MICROSTRUCTURE

     

    NOVEL-SPUN INNER GRAFT LAYER

    Reduces fibrin deposition and thrombus formation without coatings or drugs.1

    Image shows comparison of the PTFE microstructure in WRAPSODY CIE vs leading covered stent manufacturer

    CELL-IMPERMEABLE MIDDLE LAYER*

    Prevents transmural cellular migration and tissue accumulation.

    Image shows the extent of cellular migration within the WRAPSODY CIE vs a leading covered stent

    * Based upon evaluation of the device in an ovine external iliac artery model
    Cross-Sectional Histology Images: Left External Iliac, Animal, 180 days. Dolmatch, et al. JVIR. 2020; 31: 494–502. Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model (ref 2)

    BIOCOMPATIBLE ePTFE OUTER LAYER

    Designed to allow tissue ingrowth to prevent endoprosthesis migration.

    Representation of the outer ePTFE on the left, and tissue ingrowth on the right

     

     

    OPTIMIZED RADIAL STRENGTH AND COMPRESSION RESISTANCE

    The WRAPSODY CIE has consistent radial strength and robust local compression resistance across all diameter sizes, allowing the WRAPSODY CIE to withstand both intraluminal forces as well as extrinsic pressures placed on the device.1

    Image shows the comparison of compression of the WRAPSODY stent vs leading competitors

    WRAPSODY CIE versus 10 mm leading covered stent, each compressed by 1.8 N.

     

     

    SOFTENED END ROWS

    The WRAPSODY CIE has end rows with less radial force designed to better conform to healthy vessel tissue, prevent vessel trauma, and improve long-term patency.

    1) Softened End Rows with less radial force.1

    2) Nitinol Struts allow for upsizing of up to 25% for superior vessel conformance.1

     

     

     

    CLINICAL EVIDENCE

    “The six-month efficacy data is compelling and provides clinicians the chance to evaluate how WRAPSODY can help us prolong the vascular access of our patients. WRAPSODY should be the new standard of care for these patients.”
    – Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, Calif., and Co-Principal Investigator of the WAVE trial.

     

    6-Month Arteriovenous Fistula (AVF) Target Lesion Primary Patency – Covered Stents Vs. PTA3

    6-Month Arteriovenous Graft (AVG) Target Lesion Primary Patency – Covered Stents4
    Patency rates are defined differently; data comes from different individual studies and may differ in a head-to-head comparison, and therefore may not be predictive of clinical results.

     

     

    PINPOINT ACCURACY

    1 – Racheted Deployment Handle
    for one-handed accurate and controlled WRAPSODY CIE placement

    2 – Single Port
    for flushing guide wire lumen and WRAPSODY CIE pod

    3 – Safety Clip
    to prevent inadvertent deployment

    4 – Radiopaque Marker Bands
    for enhanced visualization

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

     

     

    HYDROPHILIC COATING

    Allows smooth insertion & withdrawal, along with exceptional trackability

    REFERENCES

    1. Data on file.

    2. Dolmatch et al. 2020. “Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model.” Journal of Vascular and Interventional Radiology 21, no. 3 (March): 494-502. doi.org10.1016/j.jvir.2019.07.036. (PMID: 31959517)

    3. Razavi. “Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY® Arteriovenous Access Efficacy (WAVE) trial”. PowerPoint presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) scientific symposium, Lisbon, Portugal, September, 2024.

    4. Razavi. “Six-month safety and efficacy outcomes from the WRAPSODY® Arteriovenous Access Efficacy (WAVE) trial”. PowerPoint presented at the annual VEITH symposium, November, 2024.

    document

    Documents

    Clinical Data

    Important Information
    • New Technology Add-On Payment (NTAP) Guide for WRAPSODY CIE – FY 2026

     

    Current IFU
    • WRAPSODY Cell-Impermeable Endoprosthesis (CIE) – IFU (US Version)

     

    Current Brochure
    • WRAPSODY Cell-Impermeable Endoprosthesis (CIE) – Brochure (US Version)

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    Order Information

    Note: Robust size range available, including 14 mm and 16 mm diameter sizes that are unique to Merit Medical.

    409072001_001  ID 121924