Endoprosthesis

Designed to extend long-term vessel patency in patients with obstructions in the dialysis outflow circuit.

· · ·· · DEVICE · · · · ·

DESIGNATION

BREAKTHROUGH

★★★

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The Merit WRAPSODY Endoprosthesis offers a wide range of innovative features unlike any other stent graft device on the market, each designed to maintain long-term vessel patency.

UNIQUE TRI-LAYERED ENDOPROSTHESIS MICROSTRUCTURE

Inside Novel-Spun PTFE Graft Layer

Middle Cell-Impermeable Graft Layer

Outer ePTFE Standard Layer

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| INSIDE NOVEL-SPUN GRAFT LAYER

The innermost layer of the Merit WRAPSODY is made of a biocompatible, novel-spun PTFE layer designed to limit inflammation and thrombus formation without coatings, chemicals, or drugs.

| MIDDLE CELL-IMPERMEABLE GRAFT LAYER

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

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Novel-spun PTFE microstructure, Merit WRAPSODY

Traditional ePTFE microstructure, Leading Stent Graft Manufacturer

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 Merit WRAPSODY and a leading ePTFE covered stent.

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

Conclusion: The Merit 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. Visit merit.com/wrapsody/dolmatch for full article summary.

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Merit WRAPSODY Leading Covered Stent

2 mm 2 mm

Cellular migration and tissue accumulation across ePTFE layers

Cell-impermeable middle graft layer

Inner lumen with no cellular migration

Inner lumen with cellular migration

| OUTER ePTFE STANDARD LAYER

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

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Outer PTFE (left), Tissue ingrowth (right)

OPTIMISED RADIAL STRENGTH AND COMPRESSION RESISTANCE

Designed to extend long-term vessel patency, the Merit WRAPSODY has consistent radial strength and robust local compression resistance across all diameter sizes, allowing the covered stent to withstand both intraluminal forces as well as extrinsic pressures placed on the device.

Consistent Radial Force: Helps prevent vessel trauma once the stent is deployed within the vessel.

Compression Resistance: Designed to withstand extrinsic pressures placed on the device.

LOCAL COMPRESSION DEVICE COMPARISON2

Merit WRAPSODY versus 10 mm leading covered stent, each compressed in the centre by 1.8 N.

5.2 mm 4.3 mm 4.1 mm 1.3 mm

Merit WRAPSODY Three Leading Covered Stents

Softened End Rows

Nitinol Strutsallow for upsizing of up to 25% for superior vessel conformance.2

SOFTENED END ROWS

Excessive graft oversizing leads to edge stenosis and a gradual decrease in vessel patency. The Merit WRAPSODY is designed with end rows that have less radial force to better conform to healthy vessel tissue, prevent vessel trauma, and improve long-term patency.

A DECADE OF INNOVATION

The Merit WRAPSODY is the result of Merit Medical’s commitment to understanding the unmet needs of clinicians and innovating solutions that produce better patient outcomes.

2011AUG// Merit WRAPSODY product

development begins.

2012FEB// Novel-spun PTFE is discovered.

JUL// Small animal studies initiated.

2013APR// Large animal pilot

studies initiated.

2014JAN// Merit WRAPSODY design

modified to include cell- impermeable layer.

JUN// Large animal pilot study con-

ducted for new stent graft design.

2016JAN// Pilot production line set

up in cleanroom.

MAY// Hydrophilic coating developed

for delivery catheter.

2017JAN// Good laboratory practice (GLP)

animal study initiated.

2018NOV// Merit WRAPSODY ready

for human implant.

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Softened End Rowswith less radial force.2

Hydrophilic coating enables smooth stent graft insertion and withdrawal through the delivery sheath and exceptional trackability through tortuous vasculature.

INTUITIVE DELIVERY SYSTEM FOR PINPOINT ACCURACY

The Merit WRAPSODY incorporates a coaxial system designed to improve physician efficiency.

Ratcheted deployment handlefor one-handed accurate and controlled stent graft placement.

Single portfor flushing guide wire lumen and stent graft pod.

Safety clipto prevent inadvertent deployment.

Soft atraumatic tipfor a seamless transition over a 0.035" guide wire.

Radiopaque

marker bandsfor enhanced visualisation.

2019JAN// First-in-man trial begins. • Oxford, England,

United Kingdom • Athens, Greece • Glasgow, Scotland

NOV// Merit WRAPSODY receives

FDA Breakthrough Device Designation in the US.

• Thoracic central veins in AV fistula patients

2020JAN// Merit WRAPSODY first-in-man

trial patient completes 1-year follow up.

FEB // Merit WRAPSODY first-in-man

trial enrolls 46th patient.

MAR// Merit WRAPSODY receives

expanded FDA Breakthrough Device Designations in the US.

• Thoracic central veins in AV graft patients

• Peripheral arm veins in AV fistula patients

// Article published in JVIR by Dolmatch, et al.: Evaluation of a Novel Spun Polytetrafluoro-ethylene Stent Graft in an Ovine External Iliac Artery Model.

MAY // Merit WRAPSODY

receives CE Mark

2021JAN// WRAPSODY Arterio-Venous

Endoprosthesis (WAVE) IDE pivotal trial set to begin.

MORE DIAMETER SIZES TO TREAT THE DIALYSIS OUTFLOW CIRCUIT

The Merit WRAPSODY is the only covered stent on the market with 14 mm and 16 mm diameter options specifically designed to treat the thoracic central veins.

MERIT WRAPSODY DIAMETERS

6 mm 7 mm 8 mm 9 mm 10 mm 12 mm 16 mm14 mm

Thoracic central vein options

DELIVER WITH CONFIDENCE

Watch the video animation to see the Merit WRAPSODY in action. Visit merit.com/wrapsody.

6x125

16x30

MERIT WRAPSODY LENGTHS

The Merit WRAPSODY is available in lengths ranging from 30 mm to 125 mm.

This product is intended for sale and/or use only in the European Union, for use in haemodialysis patients for the treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft. This product is not approved, cleared or available for sale or use in the United States, and may not be approved, cleared or available for sale or use in other countries. Before using any product, refer to the Instructions for Use (IFU) for indications, contraindications, warnings, precautions, and directions for use.

Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, Utah 84095Main: +1.801.253.1600Customer Service: +1.801.208.4300

Merit Medical Europe, Middle East, & Africa (EMEA)Amerikalaan 42, 6199 AE Maastricht-Airport The Netherlands+31 43 358 82 22

Merit Medical Ireland Ltd.Parkmore Business Park WestGalway, Ireland+353 (0) 91 703 733

merit.com 703933101_002 ID080620

REFERENCES1. Dolmatch, Bart L., John W. Hall, Wayne L. Mower, and Serge D. Rousselle. 2020. “Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in

an Ovine External Iliac Artery Model.” Journal of Vascular and Interventional Radiology 31: 494–502. https://doi.org/10.1016/j.jvir.2019.07.036.2. Data on file.

Catalog Number

Catheter Working Length

Stent Graft Diameter

Stent Graft Length

French Size

WRAP-S06050 80 cm 6 mm 50 mm 8F

WRAP-S06075 80 cm 6 mm 75 mm 8F

WRAP-S06100 80 cm 6 mm 100 mm 8F

WRAP-S06125 80 cm 6 mm 125 mm 8F

WRAP-S07050 80 cm 7 mm 50 mm 9F

WRAP-S07075 80 cm 7 mm 75 mm 9F

WRAP-S07100 80 cm 7 mm 100 mm 9F

WRAP-S07125 80 cm 7 mm 125 mm 9F

WRAP-S08050 80 cm 8 mm 50 mm 9F

WRAP-S08075 80 cm 8 mm 75 mm 9F

WRAP-S08100 80 cm 8 mm 100 mm 10F

WRAP-S08125 80 cm 8 mm 125 mm 10F

WRAP-S09050 80 cm 9 mm 50 mm 10F

WRAP-S09075 80 cm 9 mm 75 mm 10F

WRAP-S09100 80 cm 9 mm 100 mm 11F

WRAP-S09125 80 cm 9 mm 125 mm 11F

WRAP-L06050 120 cm 6 mm 50 mm 8F

WRAP-L06075 120 cm 6 mm 75 mm 8F

WRAP-L06100 120 cm 6 mm 100 mm 8F

WRAP-L06125 120 cm 6 mm 125 mm 8F

WRAP-L07050 120 cm 7 mm 50 mm 9F

WRAP-L07075 120 cm 7 mm 75 mm 9F

WRAP-L07100 120 cm 7 mm 100 mm 9F

WRAP-L07125 120 cm 7 mm 125 mm 9F

WRAP-L08050 120 cm 8 mm 50 mm 9F

WRAP-L08075 120 cm 8 mm 75 mm 9F

WRAP-L08100 120 cm 8 mm 100 mm 10F

WRAP-L08125 120 cm 8 mm 125 mm 10F

Catalog Number

Catheter Working Length

Stent Graft Diameter

Stent Graft Length

French Size

WRAP-L09050 120 cm 9 mm 50 mm 10F

WRAP-L09075 120 cm 9 mm 75 mm 10F

WRAP-L09100 120 cm 9 mm 100 mm 11F

WRAP-L09125 120 cm 9 mm 125 mm 11F

WRAP-L10050 120 cm 10 mm 50 mm 11F

WRAP-L10075 120 cm 10 mm 75 mm 11F

WRAP-L10100 120 cm 10 mm 100 mm 12F

WRAP-L10125 120 cm 10 mm 125 mm 12F

WRAP-L12030 120 cm 12 mm 30 mm 12F

WRAP-L12040 120 cm 12 mm 40 mm 12F

WRAP-L12050 120 cm 12 mm 50 mm 12F

WRAP-L12060 120 cm 12 mm 60 mm 12F

WRAP-L12070 120 cm 12 mm 70 mm 12F

WRAP-L12080 120 cm 12 mm 80 mm 12F

EXCLUSIVE TO MERIT WRAPSODY

WRAP-L14030 120 cm 14 mm 30 mm 12F

WRAP-L14040 120 cm 14 mm 40 mm 12F

WRAP-L14050 120 cm 14 mm 50 mm 12F

WRAP-L14060 120 cm 14 mm 60 mm 14F

WRAP-L14070 120 cm 14 mm 70 mm 14F

WRAP-L14080 120 cm 14 mm 80 mm 14F

WRAP-L16030 120 cm 16 mm 30 mm 14F

WRAP-L16040 120 cm 16 mm 40 mm 14F

WRAP-L16050 120 cm 16 mm 50 mm 14F

WRAP-L16060 120 cm 16 mm 60 mm 14F

WRAP-L16070 120 cm 16 mm 70 mm 14F

WRAP-L16080 120 cm 16 mm 80 mm 14F

ORDERING INFORMATION

Endoprosthesis