Device Dossier

HeRO – Venous Outflow Component - Catheter, haemodialysis, implantable

Device Dossier for HeRO – Venous Outflow Component - Catheter, haemodialysis, implantable (Catheter, haemodialysis, implantable, Class III, sponsor Merit…

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 long-term access solution for access-challenged and catheter-dependent patients. 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 haemodialysis access. The Venous Outflow Component consists of radiopaque silicone with braided nitinol reinforcement and a radiopaque marker band at the tip.

TGA Public Summary