HeRO Graft (Hemodialysis Reliable Outflow) is the only fully subcutaneous AV access solution clinically capable of maintaining long-term access in haemodialysis patients with central venous stenosis. HeRO Graft is classified by the US FDA as a graft, but differs from a conventional AV graft in that it has no venous anastomosis. It consists of two primary components:
A patented arterial implant component made of ePTFE
The HeRO Graft arterial implant component has an inner diameter (ID) of 6 mm, an outer diameter (OD) of 7.4 mm and a length of 53 cm, including connector. It consists of an ePTFE haemodialysis implant with PTFE ribbing to provide kink resistance in the vicinity of the patented titanium connector. The titanium connector attaches the arterial implant component to the venous outflow component. The arterial implant component is cannulated using a standard technique according to KDOQI guidelines.
A patented venous outflow component
The HeRO Graft venous outflow component has an ID of 5 mm, an OD of 19F (6.3 mm) and is 40 cm long. It consists of radio-opaque silicone with braided nitinol reinforcement (for resistance to bending and crushing) and a radio-opaque marker at its distal end.
Fewer infections: infection rate reduced by 69% compared to catheters (1).
Superior adaptation to dialysis: 1.7 Kt/V: 16% to 32% improvement over catheters (1).
High patency rates: up to 87% 2-year cumulative patency (1,2).
Cost savings: average savings of 23% per year compared to catheters (3).
1. Katzman et al, J Vasc Surg, 2009; Comparisons to catheters are from literature review on file.
2. Gage et al., EJVES 2012.
3. Dageforde et al., JSR 2012.
Indications for use
Hero Graft is indicated for haemodialysis patients with chronic renal failure who have exhausted all peripheral access routes. See Instructions for Use for full indications and contraindications. RX only.
HeRO Graft is classified by the FDA as Vascular Graft.
1. Using endovascular Seldinger technique, the intravenous component is placed in the upper third of the right atrium
2. At the level of the deltoid-pectoral groove, the titanium connector is connected to the endovascular component.
3. Standard anastomosis between ePTFE graft and target artery (>3mm).
Control and observation of dialysis vascular access:
Failure of AVF or AVG?
Is the patient catheter dependent or about to become catheter dependent?
Is the currently measured Kt/V less than 1.4?
Does the patient have swollen arms, limb oedema or prominent collateral veins on the chest?
Has the patient undergone many operations (e.g. angioplasty)?
Does the patient have central vessel stenosis?
If the answer is yes to any of the above specifications, a Central Venography is recommended to assess the status of central venous stenosis.
Surgical evaluation for Hero Graft:
Bilateral Central Venography to confirm central venous stenosis;
Vessel mapping to confirm artery diameter is ≥ 3mm;
Medical treatment for hypercoagulation;
Ejection fraction ≥ 20%;
Systolic pressure ≥ 100mmHg;