Device Dossier

HeRO Arterial Graft Component - Graft, vascular, synthetic

Device Dossier for HeRO Arterial Graft Component - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor Merit Medical). ARTG…

Intended purpose

The HeRO (Haemodialysis Reliable Outflow) Graft is intended for use in maintaining long-term vascular access for chronic haemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

Functional description

The HeRO graft is a subcutaneous AV access solution to maintain long-term access for haemodialysis patients with central venous stenosis. The arterial graft component consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector (the titanium connector attaches the Arterial to the Venous Outflow Component). A standard arterial anastomosis is performed to attach the component to the target inflow artery.

TGA Public Summary