Artivion, Inc. HERO 1004 HeRO® Graft Adapter

The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-challenged and catheter-dependentpatients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of a proprietary Venous Outflow Component and only one of the following options:• The Arterial Graft Component (not included)• The Adapter (a separate commercially available 6mm ID vascular graft is not included with the Adapter)The Venous Outflow Component (not included) has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. Itconsists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker bandat the tip.The Adapter connects a 6mm ID vascular graft (not included) to the Venous Outflow Component. The Adapter (titanium) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter. See Instructions for Use for further details regarding the grafts permitted for use with the Adapter.