Alert Indications, Safety, and Warnings

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

A Fast, Efficient, Nonsurgical Approach To Fistula Creation

  • Patented tissue fusion technology enables immediate, minimally invasive creation of permanently fused anastomosis.1
  • Track record of achievement in over 3,0002 procedures in hospital outpatient department, ambulatory surgery center, and office-based lab settings.
  • The only endoAVF system with pivotal trial data conducted in the United States1 with a peer-reviewed publication of patency outcomes through two years.3

How it Works

Transform Your AV Fistula Creation

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

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Product Performance

Proven Performance

  • 91.6% cumulative patency at two years3
  • 3,000+ successful endoAVF procedures2
  • 18+ peer-reviewed publications2
  • HIGH technical success, maturation, and cannulation rates1,3,4

Case Videos

Watch vascular surgeon Dr. Alexandros Mallios create an AV fistula using the Ellipsys vascular access system.
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Watch a typical Ellipsys vascular access system procedure as interventional nephrologist Dr. Rashid Sharaf walks through a case.
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Visit Medtronic Academy for in-depth case and training videos.

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Specifications

Ellipsys Vascular Access System

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

AMI 6005

Ellipsys Vascular Access Catheter (6F, disposable)
Ellipsys vascular access system controller on white background

AMI 1001

Ellipsys Power Controller (110–240V, 50/60Hz, reusable)

Additional device: Crossing Needle Model No. AMI-3000

 

Additional Resources

*

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

Data on file at Medtronic.

3

Beathard GA, Litchfield T, Jennings WC. Two-year cumulative patency of endovascular arteriovenous fistula. J Vasc Access. May 2020;21(3):350-356.

4

Shahverdyan R. Comparison of Surgical (sAVF) and Percutaneous (pAVF) Arteriovenous Fistulae. Presented at LINC 2021.