Arteriovenous fistula creation

Ellipsys™ vascular access system

Arteriovenous fistula creation

Ellipsys™ vascular access system

The Ellipsys™ system is a single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula.

Ordering information
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Indications, Safety, and Warnings

Description

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.

Features

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

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The distal tip of the Ellipsys vascular access system is the end-point of the catheter which is used to create a percutaneous AV fistula.

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

Risks may include: total/partial occlusion or stenosis of the anastomosis, failure to achieve fistula maturation, Steal Syndrome, hematoma, infection, and need for vessel superficialization or other maturation assistance procedures.

Case videos


Watch vascular surgeon Dr. Alexandros Mallios create an AV fistula using the Ellipsys™ vascular access system. (06:45)


Watch a typical Ellipsys™ vascular access system procedure as interventional nephrologist Dr. Rashid Sharaf walks through a case. (18:13)

Ordering information

Item number Description Recommended introducer sheath (Fr) Guidewire compatibility (in) Vessel size (mm)
AMI6005 Ellipsys™ catheter‡ 6§ 0.014 2.0 +

 

Item number Description Units per pack
AMI1001 Ellipsys™ power controller (reusable) 1
K21-00022 EndoAVF™ access kit hydrophilic sheath◊ 5

 

Resources

Related links

† Compared to surgical arteriovenous fistulas.

‡ Requires AMI-1001 Ellipsys™ power controller (110-240 V, 50/60 Hz, reusable).

§ Maximum sheath length 10 cm. Prior to using a specific sheath, ask your sales or clinical representative if the sheath is compatible with the Ellipsys catheter. Sheaths that are too long may cover the working portion at the device tip.

◊ Includes 21 ga x 7 cm echo-tip micropuncture needle, 0.018” guidewire, and 6 Fr x 10 cm thin-walled radial artery sheath.

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

  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. 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. 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. 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. 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.  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. 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. 2020;31(9):1365–1372.