The HeRO Graft consists of the Venous Outflow Component* (HERO 1001) and ONE of the following options:
HeRO Graft Options
|COMPONENT||PRODUCT IMAGE||OPTION 1:|
|ePTFE graft*,✝,✦||N/A||✔||Table 2✦||No image available|
- *Sold separately.
- ✝ The Adapter connects a 6mm ID ePTFE vascular graft ✦ (not included) and the Venous Outflow Component (not included).
- Only the ePTFE grafts in Table 2 below (not available from CryoLife) have been tested and are permitted for use with the Adapter.
- See HeRO Graft Adapter Instructions for Use (IFU) for full details.
- ‡ Accessory Component Kit is sold separately and provides instruments and accessories that may aid in the placement of the HeRO Graft.
- N/A = not applicable
✦Table 2: US Marketed 6mm ID Vascular Grafts (Tested with Adapter)
|TRADE NAME||MANUFACTURER||LENGTH||WALL||CATALOGUE NUMBER|
|GORE® ACUSEAL1||W.L. Gore & Associates||40cm||–||ECH060040A|
|FLIXENE® Standard Wall2||Atrium Medical Corporation||10cm, 30cm, 50cm||SW||25053, 25142, 25052|
- SW = Standard Wall
- General Warning: The Adapter should NOT be connected to any graft other than a new graft listed in Table 2.
**NOTE: The GORE ACUSEAL Vascular Graft is available through W.L. Gore & Associates. The FLIXENE Standard Wall Vascular Graft is available through Atrium Medical (Maquet Getinge Group).
Venous Outflow Component
The HeRO Graft Venous Outflow Component has a 5mm ID, 19F (6.3mm) OD, and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the distal tip.
- No venous anastomosis
- Reinforced 48 braid nitinol: kink & crush resistant
- Removable and replaceable
- Radiopaque band (at distal tip)
Arterial Graft Component
The HeRO Graft Arterial Graft Component has a 6mm inner diameter (ID), 7.4mm outer diameter (OD), and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the proprietary titanium connector. The titanium connector attaches the Arterial Graft Component to the Venous Outflow Component and has a 6mm to 5mm (ID). The Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.
- Beading (3-4cm) for kink resistance
- Orientation line on graft to guide placement during tunneling
- Titanium connector
Accessory Component Kit
The Accessory Component Kit provides instruments and accessories that may aid in the placement of the HeRO Graft Venous Outflow Component.
- W.L. Gore & Associates. GORE ACUSEAL Vascular Graft Configurations. http://www.goremedical.com/acusealvg/configurations/, downloaded on 08/29/2013.
- Atrium Medical Corp. Product Catalog, Vascular Grafts, Vascular Patches and Tunnelers, Dec. 2, 2011. Product FLIXENE Vascular Graft, Standard Wall. http://www.atriummed.com/EN/vascular/Documents/US%20Grafts%20Catalog.pdf, downloaded on 08/29/2013.