Ellipsys Fistula for Hemodialysis Access

The study would like to enroll up to 100 patients without age, gender-based, race and
ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing
potential are not excluded. If a pregnant patient required, an arteriovenous fistula for
hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent
previous Ellipsys® patients with appropriate medical records so that the Investigator may
capture participants data for outcomes reporting.

Inclusion Criteria:

- Patient age > 18 years or older

- Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start
of dialysis

- Adjacent vein diameter of > 2.0 mm at target anastomosis site and confirmed clinically
significant outflow

- Arterial lumen diameter of > 2.0 mm at target anastomosis site

- Adequate collateral arterial perfusion: Barbeau test grade A through C

- Radial artery -adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge via
ultrasound

Exclusion Criteria:

- Target vessel that are < 2mm is diameter

- Distance between the target artery and vein > 1.5 mm

- Edema of the upper extremity on the ipsilateral side

- Barbeau test grade D