Project Description

HeRO Graft (Hemodialysis Reliable Outflow) is the ONLY fully subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients withcentral venous stenosis. 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.

Key Benefits:

  • Fewer Infections: 69% reduced infection rate compared with catheters. 1
  • Superior Dialysis Adequacy: 1.7 Kt/V, a 16% to 32% improvement compared with catheters. 1
  • High Patency Rates: Up to 87% cumulative patency at 2 years. 1,2
  • Cost Savings: A 23% average savings per year compared with catheters. 3

1. Katzman et al., J Vasc Surg, 2009; Comparisons to catheters are from literature review on file.
2. Gage et al., EJVES 2012.
3. Dageforde et al., JSR 2012.

Hero Graft Procedura Chirurgica

Indications For Use

The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. See Instructions for Use for full indication, contraindication and caution statements. RX only.

FDA Classification

HeRO Graft is classified by the FDA as a vascular graft prosthesis.

Procedure Overview

1. Utilizing endovascular techniques, the Venous Outflow Component is placed in the central venous vasculature to the opening of the right atrium.

2. At the deltopectoral groove, the proprietary titanium connector on the graft is joined with the Venous Outflow Component.

3. A standard arterial anastomosis is performed to attach the ePTFE graft to the target inflow artery (>3mm).

Identifying the target patient
hero graft nefrologia

Dialysis Access Monitoring and Surveillance:

  • Is the patient failing an AVF or AVG?
  • Is patient currently catheter-dependent or approaching catheter dependency?
  • Is the current measured Kt/V less than 1.4?
  • Has the flow rate dropped by 20%?
  • Does the patient have a swollen arm, limb edema, or prominent chest wall collateral veins?
  • Has the patient had multiple interventions (e.g. angioplasty)?
  • Does the patient have a record of central venous stenosis?

If YES is checked for any box above, refer patient for a central venogram to assess for central venous stenosis.

Surgical Assessment for HeRO Graft may include:

  • Bilateral central venography to confirm central venous stenosis
  • Vessel mapping to confirm artery ≥ 3mm for arterial anastomosis
  • Medically-managed for hypercoagulation
  • Ejection fraction ≥ 20%
  • Blood pressure systolic ≥ 100mmHg
  • Infection-free
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Referrals:

  • HeRO Vascular Access Device
    Marc H. Glickman, MD
  • Initial experience and outcome of a new hemodialysis access device for catheter-dependent patient
    Howard E. Katzman, Robert B. McLafferty, John R. Ross, Marc H. Glickman,  Eric K. Peden and Jeffery H.  Lawson
  • Multi-center Experience of 164 Consecutive Hemodialysis Reliable Outflow [HeRO] Graft Implants for Hemodialysis Treatmentq
    S.M. Gage a,H.E. Katzman, J.R. Ross, S.E. Hohmann, C.A. Sharpe, D.W. Butterly, J.H. Lawson
  • Successful Use of the HeRO Device to Salvage a Functional Arteriovenous Fistula and Resolve Symptoms of Venous Hypertension
    G.J. Chen, J.E. Anaya-Ayala, N. Ismail, C.J. Smolock, M.G. Davies, E.K. Peden
  • Experience of HeRO Dialysis Graft Placement in a Challenging Population
    Angela A. Kokkosis, Steven D. Abramowitz, Jonathan Schwitzer, Harry Schanzer and Victoria J. Teodorescu

MERIT MEDICAL

Founded in 1987, Merit Medical set out to build the world’s most customer-focused healthcare company by understanding customers’ needs, and innovating and delivering a diverse range of products that improve the lives of people, families, and communities throughout the world.

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