Unmet Need

AV Fistula

AV-FistulaVascular access is the lifeline for more than 600,000 dialysis patients in the United States and more and 2 million patients world wide. The arteriovenous (AV) fistula is the gold standard for establishing vascular access. An AV fistula is created by suturing an artery to a vein, increasing the pressure in the vein.  This increase in pressure in the vein causes it to dilate, so that the vessel is large enough to receive the 15g needles required for dialysis. It can take up to 12 weeks for a fistula to mature, achieving adequate dilation so that it can be accessed during dialysis. Unfortunately, 20-50% of all AV fistulas never mature to become usable(1).

Growing Patient Population


The dialysis population is a growing at 4-6% annually. At the end of 2016, approximately 3 million people were receiving dialysis treatments world wide (Fresenius Annual Report,2016).

Annual Dialysis Costs

In 2014, Medicare spent $32.8B caring for end stage renal disease (ESRD) patients, which accounted for 7.2% of overall Medicare paid claims (2). As the ESRD patient population continues to grow, so will the costs associated with dialysis treatments.

Need for Innovation

The surgical creation of the AV fistula was first described in 1966. Since that time, little has changed about the way these access sites are created. In spite of this medical advancement, vascular access remains the “Achilles’ heel” of dialysis (3). Multiple surgical interventions are often required to maintain AV fistula patentcy (4,5). Considering the high rate of non-maturing AV fistulas, clinicians and dialysis patients are in need of an innovative solution.

  1. Dixon, B. S. (2006). Why don’t fistulas mature?. Kidney international70(8), 1413-1422.
  2. USRDS. USRDS 2015 Annual Data Report 2015 [cited 2016 August 11]. Available from: https://www.usrds.org/2015/view/v2_01.aspx.
  3. Roy-Chaudhury, P. (2016). Vascular Access Innovation in a Changing Health Care Environment. Endovascular Today, 15(6), 3-5. 
  4. Peterson W.J., Barker J., Allon M. (2008). Disparities in Fistula Maturation Persist Despite Preoperative Vascular Mapping. Clin J Am Soc Nephrology, 3, 437-441.
  5. Kimball, T. A., Barz, K., Dimond, K. R., Edwards, J. M., & Nehler, M. R. (2011). Efficiency of the kidney disease outcomes quality initiative guidelines for preemptive vascular access in an academic setting. Journal of vascular surgery54(3), 760-766.