Device Description; Intended Use; Indications For Use - CryoLife HeRo GRAFT Mode D'emploi

INSTRUCTIONS FOR USE
Federal (USA) law restricts this device to sale by or on the order of a physician.
Only qualified healthcare providers should place, manipulate, de-clot, revise or explant the device.
Carefully read all instructions prior to use.
Adhere to universal precautions when inserting, maintaining or explanting the device.
Not made with natural rubber latex.
STERILE (EO) – FOR SINGLE USE ONLY
Each component of the HeRO Graft is provided in double sterile barrier packaging and is EO sterilized in accordance with ISO
11135-1. DO NOT resterilize.
STORAGE
To provide maximum protection, store the HeRO Graft components in their original, unopened packages at room temperature.
Keep dry and out of direct sunlight. Each component must be used before the use by date printed on the individual labels.
Consult Instructions for Use
Prescription Device
Use-By Date
Do Not Re-Use
Sterilized Using Ethylene Oxide
REF
Catalogue Number
Batch Code
Authorized Representative in the
European Community

DEVICE DESCRIPTION

The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm 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 hemodialysis access.
Venous Outflow Component
HeRO Graft consists of two primary components:
• A proprietary Venous Outflow Component
• A proprietary ePTFE Arterial Graft Component
The HeRO Graft Venous Outflow Component has a 5 mm inner diameter (ID), 19F outer diameter (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 tip.
The HeRO Graft Arterial Graft Component has a 6 mm ID, 7.4 mm 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 titanium connector. The titanium connector has
a tapered ID (6 mm to 5 mm) and attaches the Arterial Graft Component to the Venous Outflow Component. The HeRO Graft
Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.
The Accessory Component Kit provides instruments and accessories that may aid in the placement of the HeRO Graft.
The FDA regulation name for the HeRO Graft is vascular graft prosthesis.

INTENDED USE

The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have
exhausted peripheral venous access sites suitable for fistulas or grafts.

INDICATIONS FOR USE

The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options.
These catheter-dependent patients are readily identified using the KDOQI guidelines
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options,
such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access
failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g., fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access
failures, symptomatic CVS (i.e., via arm, neck, or face swelling), or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.
5 mm ID
19F (6.3 mm) OD
Kink & crush resistant
nitinol reinforcement braid
Titanium
connector
ENGLISH
MR Conditional
Non-Pyrogenic
Do Not Resterilize
Manufacturer
Keep Dry
Keep Away from Sunlight
Do Not Use if Package is Damaged
40cm silicone-coated
outflow component
PTFE
beading
Arterial Graft Component
2
Radiopaque
marker band
50cm ePTFE
6 mm ID
hemodialysis
7.4 mm OD
vascular graft
as patients who:
1
2