The HeRO (Hemodialysis Reliable Outflow) 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. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Arterial Graft Component has a 6mm ID, 7.4mm 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 attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.

The HeRO (Hemodialysis Reliable Outflow) Graft is a long
HeRO® Graft Arterial Graft Component - HERO 1002

An implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.

• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MSD

Device Name: Catheter, Hemodialysis, Implanted

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5540

Third Party Flag: N

Medical Specialty: GU

Code: LJS

Device Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 880.5970

Third Party Flag: N

Medical Specialty: HO

Code: DSY

Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3450

Third Party Flag: N

Medical Specialty: CV

Device Id: 00877234000072

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A