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HeRO Graft ADAPTER

HeRO Graft ADAPTER

HeRO Graft ADAPTER

Product catalog summary
Overview: The document discusses the HeRO (Hemodialysis Reliable Outflow) Graft, a subcutaneous vascular access solution for hemodialysis patients with central venous stenosis. It highlights the benefits, specifications, and procedures related to the use of the HeRO Graft and its components.
Key Features and Benefits:
  • Superior Dialysis Adequacy: Provides a 16% to 32% improvement in dialysis adequacy compared to catheters.
  • High Patency Rates: Up to 87% cumulative patency at 2 years.
  • Reduced Infections: 69% lower infection rate compared to catheters.
  • Cost Benefits: Offers significant cost savings, including a 23% average annual savings and over $3,100 savings per patient per year for dialysis centers.
Components and Specifications:
  • HeRO Graft Adapter: Connects a 6mm ID ePTFE vascular graft to the Venous Outflow Component. It features a tapered ID for smooth transition.
  • GORE ACUSEAL Vascular Graft: Allows early cannulation within 24 hours post-implantation.
  • Table 1: Lists US marketed 6mm ID vascular grafts tested with the Adapter, including GORE ACUSEAL and FLIXENE Standard Wall.
Procedure and Assembly:
  • Instructions for assembling the Adapter with a new graft, ensuring proper advancement to the Adapter shoulder, and securing with clamshells.
  • Warnings against premature closure of clamshells and using untested grafts.
Identifying Candidates for HeRO Graft:
  • Criteria include catheter dependency, failing AVF or AVG, central venous stenosis, swollen arms, and reduced Kt/V.
  • Recommendation for central bilateral venogram assessment if criteria are met.
Cost Impact:
  • Significant cost reductions in missed dialysis sessions, outpatient IV antibiotic use, and other interventions.
References: The document cites various studies and data sources supporting the benefits and efficacy of the HeRO Graft.
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Catalog excerpts

HeRO Graft ADAPTER-1

Featuring an early cannulation graft option* More Graft Options** • GORE® ACUSEAL • FLIXENE® Standard Wall *See inside and Instructions for Use (IFU) for more details. **Graft is not included with the Adapter. See IFU for more details on the ePTFE grafts that have been tested and are permitted for use with the Adapter. Life Restoring Technologies

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HeRO Graft ADAPTER-2

HeRO Graft HeRO (Hemodialysis Reliable Outflow) Graft is the ONLY fully subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis. HeRO Graft Adapter connects a 6mm ID ePTFE vascular graftu (not included) and the Venous Outflow Component (VOC, not included). The Adapter has a tapered ID (6mm to 5mm) to provide a smooth transition from the graft to the VOC. Treatment Algorithm Failing AVF or AVG due to central venous stenosis Catheter-dependent patients Key Benefits • Superior Dialysis Adequacy: 1.7 Kt/V, a 16% to 32%...

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HeRO Graft ADAPTER-3

Adapter Assembly Overview 1. Select a new graft (not included) from Table 1. General Warning: The Adapter should NOT be connected to any graft other than a new graft listed in Table 1. Table 1: US Marketed 6mm ID Vascular Grafts (Tested with Adapter) Trade Name Catalogue Number FLIXENE Atrium Medical 10cm SW 25053 5 Standard Wall Corporation 30cm 25142 50cm 25052 SW = Standard Wall 2. Insert Graft Expander into graft. Advance graft up to shoulder as much as possible and leave in place. 3. Ensure clamshells are open and centered around the Adapter base. ATTENTION: The clamshells CANNOT be opened...

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HeRO Graft ADAPTER-4

Identifying a HeRO Graft Candidate • Is the patient currently catheter dependent or approaching catheter dependency? • Does the patient have a record of central venous stenosis? • Does the patient have swollen arms and/or distended collateral veins? • Is the measured Kt/V less than 1.4? • Has the flow rate dropped >20%? If YES n is checked for any box above, consider referring patient for a central bilateral venogram for assessment of central venous stenosis. Cost Benefits* • 3% average savings per year with the HeRO 2 Graft compared with catheters7 • Cost savings of over $3,100 (per patient/year)...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.