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Care Continuum

Ellipsys™ vascular access system

Optimize the care continuum

Build a successful program for the Ellipsys™ Vascular Access System with resources and best practices designed to enhance patient selection, fistula creation, maturation, and cannulation.

Alert Indications, Safety, and Warnings
Healthcare professional in blue scrubs with a stethoscope talking to an older man

Four pillars of success

To deliver the best patient outcomes with the Ellipsys™ System, healthcare practitioners need to develop a support program with four fundamental pillars:

Patient selection

Candidate patients may include up to 65% of the general end-stage kidney disease (ESKD) population.1-6

Arterial requirements

  • Proximal radial artery diameter (> 2 mm)
  • No inflow restrictions
  • Calcification (non-occlusive)
  • Patent palmar arch

Perforator requirements

  • Diameter (> 2 mm)
  • Proximity to artery (< 1.5 mm)
  • Must be straight enough to allow 21 Ga needle to be guided inside the lumen

Outflow vein anatomy*

  • Verify patency of the basilic and cephalic veins
  • Check for thrombosis
  • Diameter (> 2 mm)

Ultrasound screening

Early vein mapping is critical for establishing patient qualification.

Vein mapping

Vein rescreening on the day of the procedure helps confirm patient readiness and prepare the care team to perform the procedure successfully.

Fistula creation

Ellipsys offers the simplest, most minimally invasive option for arteriovenous fistula (AVF) creation.*1,2 With best-in-class training and education from Medtronic, vascular surgeons, interventional radiologists, and interventional nephrologists can perform the Ellipsys™ Procedure.

  • Single point of venous access1
  • Percutaneous equivalent to the surgical Gracz fistula1
  • Located between the proximal radial artery (PRA) and deep communicating vein (DCV)1

Step-by-step overview

Watch the video to see exactly how the Ellipsys™ Procedure is performed.

  1. Venous access
  2. Arterial puncture
  3. Sheath insertion
  4. Catheter positioning
  5. Catheter activation
  6. Balloon dilation
  7. Assessment

Maturation

To meet requirements for successful cannulation, follow-up is recommended at one week and four weeks to assess fistula development.

Monitor and complete maturation assessment of dialysis readiness.

Track flow volume of the fistula to determine appropriate vessel maturation strategy for a target cannulation vessel with:

  • > 6 mm diameter
  • < 6 mm depth
  • > 500 mL/min volume flow
  • Palpable/visible access vein required for many dialysis units
Graphic of a blue circle with 1 week written inside

One-week follow-up

Verify anastomosis or perform balloon dilation if necessary.

Graphic of a blue circle with 4 weeks written inside

Four-week follow-up

Perform fistula preparation to direct flow to target vein.

Graphic of a blue circle with 6-8 weeks written inside

Six- to eight-week follow-up

Establish two-needle cannulation.

Cannulation

Most patients will have a mature fistula within six to eight weeks after creation. The access physician should determine cannulation readiness and communicate with the patient, dialysis staff, and the Medtronic representative who will serve as a liaison with the dialysis center.

Decorative element

Target cannulation vein(s)

  • Most patients cannulated with two needles in the cephalic vein.
  • Some are cannulated with one needle in the cephalic and one in the basilic (“Y” configuration).
  • Ellipsys fistulas meet the same general criteria as surgical AVF:
    • > 6 mm diameter
    • < 6 mm depth
    • > 500 mL/min volume flow
  • Perform maturation if needed to meet cannulation criteria:
    • Balloon dilation
    • Deep vein embolization coils
    • Cubital vein banding/ligation
    • Transpositions/lipectomy
Decorative element

Look, listen and feel

Dialysis center staff should be aware of the following variations with Ellipsys fistulas.

Look: Swelling, hematoma, aneurysm, edema, presence of multiple collateral vessels, drainage, bleeding, discoloration (pallor, redness), ischemia, ulceration

Listen: Systolic and diastolic bruit near anastomosis

Feel: Thrill near anastomosis, pulsatile, weak, firm, tender, thrombosed

Decorative element

Cannulation best practices

  • Ensure in-service is scheduled to educate the dialysis center.
  • Mark the outflow path and suggested needle placement with permanent marker.
  • Always use a tourniquet to engorge the fistula.
  • Use a shallow needle angle to avoid infiltration and damage.
  • Suggest the centers to start dialysis with 17G needles and 250 mL/min flow rates.

Build your knowledge

Learn about industry-leading technology and tools that help improve patient outcomes for Ellipsys™ Procedures, including courses, webinars, videos and more.

Explore Medtronic Academy

Explore the Ellipsys™ system

See what makes Ellipsys™ the simplest, most minimally invasive option for AVF creation.

Learn more
*

Per instructions for use (IFU).

†

Compared to surgical arteriovenous fistulas.

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 Disease. October 2021;78(4):520-529.

3

Franco G, Mallios A, Bourquelet P, Hebibi H, Jennings W, Boura B. Feasibility for arteriovenous fistula creation with Ellipsys. J Vasc Access. September 2020;21(5):701-704.

4

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

5

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.

6

Popli K, Dittman JM, Amendola MF, Plum J, Newton DH. Anatomic suitability for commercially available percutaneous arteriovenous fistula creation systems. J Vasc Surg. March 2021;73(3):999-1004.