Your browser is out of date

With an updated browser, you will have a better Medtronic web site experience. Update my browser now.

×

Indications, Safety, and Warnings

Indications, Safety, and Warnings
Ellipsys™ Vascular Access System

Indications

The Ellipsys™ system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Contraindications

The Ellipsys™ system is contraindicated for use in patients with target vessels that are < 2 mm in diameter. The Ellipsys™ System is contraindicated for use in patients who have a distance between the target artery and vein > 1.5 mm.

Warnings

  • The Ellipsys™ system has only been studied for the creation of an AV fistula using the proximal radial artery and the adjacent perforating vein. It has not been studied in subjects who are candidates for surgical fistula creation at other locations, including sites distal to this location.
  • The Ellipsys™ system is not intended to treat patients with significant vascular disease or calcification in the target vessels.
  • The Ellipsys™ system has only been studied in subjects who had a patent palmar arch and no evidence of ulnar artery insufficiency.
  • Use only with the Ellipsys™ Power Controller, Model No. AMI-1001.
  • The Ellipsys™ Catheter has been designed to be used with the 6 F Terumo Glidesheath Slender™*. If using a different sheath, verify the catheter can be advanced through the sheath without resistant prior to use.
  • Use ultrasound imaging to ensure proper placement of the catheter tip in the artery before retracting the sheath, since once the distal tip of the catheter has been advanced into the artery, it cannot be easily removed without creation of the anastomosis. If the distal tip is advanced into the artery at an improper location, complete the procedure and remove the catheter as indicated in the directions for use. It is recommended that a follow-up evaluation of the patient is performed using appropriate clinical standards of care for surgical fistulae to determine if any clinically significant flow develops that require further clinical action.

Precautions

  • This product is sterilized by ethylene oxide gas.
  • Additional procedures are expected to be required to increase and direct blood flow into the AVF target outflow vein and to maintain patency of the AVF. Care should be taken to proactively plan for any fistula maturation procedures when using the device.
  • In the Ellipsys™ study, 99% of subjects required balloon dilatation (PTA) to increase flow to the optimal access vessel and 62% of subjects required embolization coil placement in competing veins to direct blood flow to the optimal access vessel. Prior to the procedure, care should be taken to assess the optimal access vessel for maturation, the additional procedures that may be required to successfully achieve maturation, and appropriate patient follow-up. Please refer to the “Arteriovenous Fistula (AVF) Maturation” section of the labeling for guidance about fistula flow, embolization coil placement, and other procedures to assist fistula maturation and maintenance.
  • The Ellipsys™ System is intended to only be used by physicians trained in ultrasound guided percutaneous endovascular interventional techniques using appropriate clinical standards for care for fistula maintenance and maturation including balloon dilatation and coil embolization.
  • Precautions to prevent or reduce acute or longer-term clotting potential should be considered. Physician experience and discretion will determine the appropriate anticoagulant/antiplatelet therapy for each patient using appropriate clinical standards of care.

Potential Adverse Events

Potential complications that may be associated with creation and maintenance of an arteriovenous fistula include, but may not be limited to, the following:

  • Total occlusion, partial occlusion or stenosis of the anastomosis or adjacent outflow vein
  • Stenosis of the central AVF outflow requiring treatment per the treatment center’s standard of care
  • Failure to achieve fistula maturation
  • Incomplete vessel ligation when using embolization coil to direct flow
  • Steal Syndrome
  • Hematoma
  • Infection or other complications
  • Need for vessel superficialization or other maturation assistance procedures.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

™* Third-party brands are trademarks of their respective owners.

UC202118381a EN

Menu
United States of America
United States of America
Contact & Support

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
0:00 / 0:00

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 (opens new window)

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.

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your information will be used and protected in accordance with our {link}

There are items that require your attention.
United States

Customer Care Team

Hours: 8:00 a.m. - 8:00 p.m. EST 

 

Phone: 763-514-4000

Toll-free: 800-633-8766

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Just to confirm, is this the product or product type that interests you?

{{productNamePlaceholder}}

OR

There are items that require your attention.

OR

There are items that require your attention.
There are items that require your attention.

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.

OR

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your personal data will be used to manage your relationship with Medtronic in accordance with our {link}

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

If you consent to receive emails, you can unsubscribe anytime via the link in each email. We use technology that measures email opens and clicks, to improve our communications and provide relevant content. For details, see our {link}