An immediate vascular access solution, from fistula-first to patient-first.

For hemodialysis patients, a "fistula first" approach has long been the standard. But fistulas can fail, 20 to 60 percent of the time,1-5 subjecting patients to undue hardship and central venous catheter (CVC)-related risks.

That's one reason 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines6 emphasize the need for a more individualized approach to access modality selection.

 It is about achieving the "right access, in the right patient, at the right time, for the right reasons." 

KDOQI guidelines

National kidney foundation logo
When patients are at risk for fistula non-maturation, turn to the GORE® ACUSEAL Vascular Graft – the purpose-built choice for rapid and long-term access for the road ahead. It is ideal for patients who are already on a CVC, or those who need a new access and must achieve cannulation in under two weeks.
It allows for earlier removal or avoidance of a CVC and helps achieve hemodialysis success with reduced access-related procedures and complications8,9 ─ for more confidence at every step. 
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Immediate cannulation:

Cannulate within 24 hours with the only FDA-cleared vascular access graft with the claim of early cannulation7

Reduced infection and mortality:

5X

lower risk of infection, compared with CVC8

3X

lower risk of mortality, compared with CVC8

Long-term access:

78%

secondary patency demonstrated at 12 months10

Lower total cost of care:

Reduces the cost of treating CVC sepsis by allowing for earlier removal of CVCs.*,11

Designed with your patients in mind
Because dialysis access is personal 

The tri-layer design of the GORE® ACUSEAL Vascular Graft is optimized for early cannulation and provides uncompromised handling. 

  • Purpose-built for immediate cannulation, designed with an elastomeric middle layer that serves as a low bleed barrier to cannulation needle holes.
  • Flexible at curves without kinking. 
Image showing the tri-layer design of the GORE ACUSEAL Vascular Graft. Abluminal layer (ePTFE graft). Elastomeric layer. Luminal layer (ePTFE with CBAS Heparin Surface)

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Reported ability to significantly reduce early thrombosis rates†,13

Reported potential to improve primary patency by up to

20%†,14

78%

clot-free survival reported at one year14

Related products

* Compared with non-immediate cannulation AV grafts. 
† Compared with standard non-heparin bonded ePTFE grafts.

  1. Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney International 2002;62(4):1109-1124.
  2. Allon M, Imrey PB, Cheung AK, et al; Hemodialysis Fistula Maturation (HFM) Study Group. Relationships between clinical processes and arteriovenous fistula cannulation and maturation: a multicenter prospective cohort study. American Journal of Kidney Diseases 2018;71(5):677-689.
  3. Dember LM, Beck GJ, Allon M, et al; Dialysis Access Consortium Study Group. Effect of Clopidogrel on early failure of arteriovenous fistulas for hemodialysis. A randomized controlled trial. Journal of the American Medical Association 2008;299(18):2164-2171.
  4. Allon M. Vascular access for hemodialysis patients: new data should guide decision making. Clinical Journal of the American Society of Nephrology 2019;14(6):954-961.
  5. Wish JB. Catheter last, fistula not-so-first. Journal of the American Society of Nephrology 2015;26(1):5-7.
  6. Lok CE, Huber TS, Lee T, et al; KDOQI Vascular Access Guideline Work Group. KDOQI Clinical Practice Guideline for Vascular Access: 2019 update. American Journal of Kidney Diseases 2020;75(4)Supplement 2:S1-S164.
  7. Marketrack: PriceTrack Database. Burlington, MA: Decision Resources Group; 2015 https://decisionresourcesgroup.com. Accessed August 14, 2017.
  8. Aitken E, Thomson P, Bainbridge L, Kasthuri R, Mohr B, Kingsmore D. A randomized controlled trial and cost-effectiveness analysis of early cannulation arteriovenous grafts versus tunneled central venous catheters in patients requiring urgent vascular access for hemodialysis. Journal of Vascular Surgery 2017;65(3):766-774.
  9. Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The clinical and economic effect of vascular access selection in patients initiating hemodialysis with a catheter. Journal of the American Society of Nephrology 2017;28(12):3679-3687.
  10. Glickman M. Early cannulation graft: Acuseal. Journal of Vascular Access 2016;17 (Supplement 1):S72-S74.
  11.  Mohr BA, Trovillion PJ. Economic value of preventing central venous catheter sepsis infections with early cannulation arteriovenous grafts (ECAVGS) compared to non-ecavgs. Presented at the ISPOR 20TH Annual International Meeting; May 16-20, 2015; Philadelphia, PA. Value in Health 2015;18(3):A42 PMD27.
  12.  Roy-Chaudhury P, Kelly BS, Melhem M, et al. Vascular access in hemodialysis: issues, management, and emerging concepts. Clinical Cardiology. 2005;23:249-273.
  13.  Shemesh D, Goldin I, Hijazi J, et al. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. Journal of Vascular Surgery 2015 Jul;62(1)115-22. doi:10.1016/j.jvs.2015.01.056. Epub 2015 Mar12. PMID: 25770987.
  14.  Davidson I, Hackerman C, Kapadia A, Minhajuddib A. Heparin bonded hemodialysis e-PTFE graft result in 20% clot free survival benefit. Journal of Vascular Access 2009 Jul-Sep;10(3):153-6. doi: 10.1177/112972980901000303. PMID:19670166. 
IFU Consult instructions

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE IN THE U.S.: GORE® ACUSEAL Vascular Grafts are intended for use as a vascular prosthesis in patients requiring vascular access.

 

INDICATIONS FOR USE IN CANADA: GORE® ACUSEAL Vascular Graft is intended for use as a vascular prostheses in patients requiring vascular access. GORE® ACUSEAL Vascular Graft is indicated for patients who require arteriovenous hemodialysis access in the upper or lower extremities for End Stage Renal Disease (ESRD).

 

CONTRAINDICATIONS: DO NOT use the GORE® ACUSEAL Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. DO NOT use GORE® ACUSEAL Vascular Grafts as a patch. If cut and used as a patch, GORE® ACUSEAL Vascular Grafts may lack adequate transverse strength.

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