Clinical Need

Access determines quality of life for hemodialysis patients

Vascular access is the dialysis patient's lifeline and has enormous impact on quality of life. Unfortunately, failure rates for current vascular access methods are exceedingly high ,thus access is considered the Achilles Heel of dialysis. Two recent NIH studies (Dialysis Access Consortium AVF and Graft studies) demonstrated poor outcomes for both AVF's and grafts. The AVF study demonstrated that 60% of AVF's were not suitable for dialysis at five months and 20% thrombosed within six weeks.1 The Graft study demonstrated that 77% of grafts fail within the first year. 2

CMS spends in excess of $1 billion per year on dialysis access site management. In 2007, there were approximately 355,000 prevalent and 100,000 incident hemodialysis patients in the U.S. By 2020, it is estimated that the U.S. dialysis population will exceed 500,000. 3

Dialysis access sites fail for many reasons. Most of these are directly affected by the quality of flow through the access site. Complications, such as those pictured below, are all too common.

ESRD 1 ESRD 2 ESRD 3 ESRD 4

Recent government initiatives such as Fistula First highlight the poor outcomes associated with access modalities. As demonstrated in recent journal publications, acute and long-term failure rates for access procedures are among the highest of any routine surgical procedure.


  1. Dember, L., "Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis, A Randomized Controlled Trial," JAMA, May 2008—Vol 299, No. 18, p. 2164-2171.
  2. Dixon, B., "Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency," NEJM, May 2009--Vol 360:2191-2201.
  3. 2008 USRDS Data, www.usrds.org