Clinical background

Vascular access grafts are used to treat patients suffering from End Stage Renal Disease (ESRD) who are scheduled to undergo hemodialysis treatment.
End Stage Renal Disease (ESRD) refers to complete kidney failure when the kidneys fail to detoxify more than 20% of excess water and waste from the body. In the U.S. alone, more than 450,000 people are undergoing treatment for the disease. By 2020 the incidence of ESRD is projected to rise to about 150,000 new cases annually for a total of 785,000 patients.

Vascular access grafts are usually implanted in the forearm, the upper arm or the thigh (depending on the patient’s anatomy). One end is anastomosed to an artery and the other end to a vein. The graft is punctured 2-3 times a week for dialysis access and needs to close quickly to minimize blood loss.
The National Kidney Foundation’s (NFK) recommends creating a native AV-Fistula (AVF – in which a native artery and an adjacent vein are connected) for vascular access whenever possible. The growing numbers of created Fistulae revealed over the years the disadvantages of this method:

  • Long maturation time.
  • Between 30-70% of the AVF’s never reach maturity and require a second surgical intervention.
  • Long bleeding times during surgery (from the suture line) and by dialysis (from the puncturing point).

 

The growing realization that fistula outcomes are unsatisfactory is expected to result in an increase in the use of AV access grafts for patients suffering from kidney failure.


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