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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Ellipsys vascular access delivery system and catheter on white background

Alert Indications, Safety, and Warnings

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 longevity^3-5 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 data^1,3 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.

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Specifications

Image	Model	Description
	AMI 6005	Ellipsys vascular access catheter (6 F, disposable)
	AMI 1001	Ellipsys power controller (110–240 V, 50/60 Hz, reusable)

Additional resources

AV fistula maintenance

Clinical summaries

24-hour technical support

1-949-276-2483
United States

Compared to surgical arteriovenous fistulas.

^†

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

References

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.

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.

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.