The HeRO Graft is a fully subcutaneous vascular access system that bypasses the central venous system to provide reliable, continuous blood flow directly from a target artery to the heart. HeRO Graft is classified by the FDA as a graft but differs from a conventional AV graft since it has no venous anastomosis. It consists of two primary components:

A proprietary ePTFE Arterial Graft Component

The HeRO Graft Arterial Graft Component has a 6mm inner diameter (ID), 7.4mm outer diameter (OD), and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the proprietary titanium connector. The titanium connector attaches the Arterial Graft Component to the Venous Outflow Component. The Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.

A proprietary Venous Outflow Component

The HeRO Graft Venous Outflow Component has a 5mm ID, 19F (6.3mm) OD, and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the distal tip.

13-0061 Rev. A