Ellipsys Vascular Access System for arteriovenous fistula (AVF) creation

Designed for end-stage renal disease (ESRD) patients requiring hemodialysis, the Ellipsys™ system is a unique single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula, a traditionally invasive procedure that — until the advent of percutaneous AVF technology — had not changed in more than 50 years.

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Overview

Less invasive, long-lasting

Only the Ellipsys vascular access system uses a single point of venous access,1 offering the simplest, most minimally invasive option for arteriovenous fistula (AVF) creation.*1,2 It provides an immediate, suture-free, permanently fused anastomosis1 that is clinically proven to improve longevity3-5 and reduce the risk of complications.3,5

Close-up image of the Ellipsys vascular access system distal tip

How it works

Explore the procedure

The Ellipsys system enables a reproducible, minimally invasive procedure that requires no implant or suture, and allows patients to leave with just a single needle stick.1

Clinical evidence

Clear clinical outcomes

The Ellipsys system is the only one of its kind with five-year U.S. clinical trial data1,3 demonstrating three critical metrics:

  • 88% maturation rate at 90 days1
  • 91.8% functional patency at five years3
  • 82% cumulative patency at five years3

Equivalent real-world result

These clinical trial maturation and patency rates have also been demonstrated in registry trial data from more than 500 real-world patients in France, Germany, and the United States.5-7

Case videos

Watch vascular surgeon Dr. Alexandros Mallios create an AV fistula using the Ellipsys vascular access system.

Watch a typical Ellipsys vascular access system procedure as interventional nephrologist Dr. Rashid Sharaf walks through a case.

Visit Medtronic Academy for in-depth case and training videos.

Specifications

Image Model Description
Ellipsys vascular access delivery system and catheter on white background

AMI 6005

Ellipsys vascular access catheter (6 F, disposable)

Ellipsys vascular access system controller on white background

AMI 1001

Ellipsys power controller (110–240 V, 50/60 Hz, reusable)

Additional resources

*

Compared to surgical arteriovenous fistulas.

The Ellipsys system and drug-coated balloons have not been used together in a clinical study.

References

1

Hull JE, Jennings WC, Cooper RI, Waheed U, Schaefer ME, Narayan R. The pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. J Vasc Interv Radiol. February 2018;29(2):149-158.e5.

2

Shahverdyan R, Beathard G, Mushtaq N, et al. Comparison of Ellipsys percutaneous and proximal forearm Gracz-type surgical arteriovenous fistulas. Am J Kidney Dis. October 2021;78(4):520-529.

3

Hull JE, Jennings WC, Cooper RI, Narayan R, Mawla N, Decker MD. Long-term results from the pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. J Vasc Interv Radiol. June 2, 2022;S1051-0443(22):974-975.

4

Franco G, Mallios A, Bourquelot P, Jennings W, Boura B. Ultrasound evaluation of percutaneously created arteriovenous fistulae between radial artery and perforating vein at the elbow. J Vasc Access. September 2020;21(5):694-700.

5

Mallios A, Bourquelot P, Franco G, et al. Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys vascular access system, technical recommendations, and an algorithm for maintenance. J Vasc Surg. December 2020;72(6):2097-2106.

6

Hull JE, Deitrick J, Groome K. Maturation for hemodialysis in the Ellipsys post-market registry. J Vasc Interv Radiol. September 2020;31(9):1373-1381.

7

Shahverdyan R, Beathard G, Mushtaq N, Litchfield TF, Nelson PR, Jennings WC. Comparison of outcomes of percutaneous arteriovenous fistulae creation by Ellipsys and WavelinQ devices. J Vasc Interv Radiol. September 2020;31(9):1365-1372.