HeRO Graft (Hemodialysis Reliable Outflow)

HeRO® Graft – Hemodialysis Reliable Outflow

The HeRO® Graft is a hemodialysis access graft for patients who are failing fistulas or grafts, or are catheter-dependent due to the blockage of veins leading to the heart. It is the only fully subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis.

Unlike a conventional AV graft, the HeRO Graft has no venous anastomosis. It is FDA-classified as a graft and consists of two primary components: a proprietary ePTFE Arterial Graft Component and a proprietary ePTFE Venous Outflow Component.

Clinical Outcomes vs. Catheters

• 69% reduced infection rate compared with catheters
• Up to 87% cumulative patency at 2 years
• 23% average cost savings per year compared with catheters
• 16–32% improved dialysis clearance of toxins and fluids (Kt/V 1.7)
• Less than half the interventions required to keep access functioning

Candidate Criteria

HeRO Graft may be appropriate for patients who are:

• Catheter-dependent or approaching catheter dependency
• Experiencing failing fistulas or grafts due to central venous stenosis

Device Components

Arterial Graft Component (ePTFE)

• 6 mm inner diameter, 7.4 mm outer diameter, 53 cm length (inclusive of connector)
• PTFE beading (3–4 cm) for kink resistance near the titanium connector
• Orientation line on graft to guide placement during tunneling
• Cannulated using standard technique per KDOQI guidelines

Venous Outflow Component (Silicone-Coated Nitinol)

• 5 mm inner diameter, 19 Fr (6.3 mm) outer diameter, 40 cm length
• Radiopaque silicone with braided nitinol reinforcement for kink and crush resistance
• No venous anastomosis
• Removable and replaceable radiopaque marker band at distal tip

Available Configurations