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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.

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Ellipsys vascular access system

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

Download brochure
Alert Indications, Safety, and Warnings

The Ellipsys vascular access system

The Ellipsys vascular access system is a unique single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula.1

  • Requires a single puncture with venous access only.1
  • Provides an immediate, suture-free, permanently fused anastomosis.1
  • Uses ultrasound guidance and does not require fluoroscopy.
  • Creates a fistula proven to increase longevity and reduce the risk of cardiovascular complications.3-5

Extensive clinical evidence

The Ellipsys system offers the most clinical data and real-world experience in its class.†1-20 It is the only one of its kind with five-year U.S. clinical trial data demonstrating three critical metrics:

88% maturation rate at 90 days1

91.8% functional patency at five years20

82% cumulative patency at five years20

More than 3,000 successful procedures21 and 20+ peer-reviewed publications1-20

 

More than 500 real-world patients in France, Germany, and the U.S. demonstrated high technical success, maturation, and cannulation rates in registry trial data.4,9,17

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.

Watch the step-by-step demonstration.

Watch the step-by-step demonstration of the Ellipsys procedure for percutaneous AVF creation by nephrologist Dr. Rashid Sharaf.

The fistula created with the Ellipsys system typically provides more moderate flow than a surgical fistula and has multiple outflows.3-5

  • Anastomosis made distal to the elbow crease.
  • Moderate flow (800–1,100 mL/min) reduces steal, heart complications, and outflow thrombus.3,4,22
  • Split outflow reduces shear stress on each vessel to help prevent aneurysm formation and central stenosis.3,4
  • Maturing multiple vessels often requires a maturation procedure four weeks post-creation.
  • Training available for interventional nephrologists and interventional radiologists.

Download the green papers.

pdf Comparison of surgical versus percutaneous created arteriovenous hemodialysis fistulas clinical paper (.pdf)

218KB

pdf Comparison on Ellipsys percutaneous and proximal forearm Gracz-type surgical arteriovenous fistulas clinical paper (.pdf)

191KB

pdf Long-term results from the pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access (.pdf)

172KB

Optimize the care continuum.

Learn how to optimize the entire care continuum for endovascular AVF creation including patient selection, fistula creation, maturation, and cannulation.

See the process
Woman in white coat and man in blue scrubs sitting down while looking at a tablet

Strengthen patient acceptance.

The Ellipsys vascular access system makes AVF creation easier on patients,1-3 improving their likelihood of acceptance4 with the most minimally invasive procedure available.1

Download clinical infographic
Decorative element

No surgery, sutures, surgical scar, or implant

Decorative element

Lower risk of cannulation segment aneurysms3,4

Decorative element

Candidate patients may include up to 65% of the general ESKD population1,2,6,9,17,23

Medtronic Academy

Learn about industry-leading technology and tools that help improve patient outcomes for Ellipsys procedures. Explore courses, webinars, PowerPoints, step-by-step procedure videos, and more.

Learn more

Coding and reimbursement resources

Get resources to assist coding, coverage, and reimbursement for the Ellipsys system.

Get resources

24-hour technical support

949-276-2483
United States

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*

Compared to surgical arteriovenous fistulas.

†

Device class is endovascular arteriovenous fistula.

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.e1.

3

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

4

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.

5

Franco G, Mallios A, Bourquelet 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.

6

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.

7

Hebibi H, Achiche J, Franco G, Rottembourg J. Clinical hemodialysis experience with percutaneous arteriovenous fistulas created using the Ellipsys vascular access system. Hemodial Int. April 2019;23(2):168-172.

8

Hull JE, Elizondo-Riojas G, Bishop W, Voneida-Reyna YL. Thermal resistance anastomosis device for the percutaneous creation of arteriovenous fistulae for hemodialysis. J Vasc Interv Radiol. March 2017;28(3):380-387.

9

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.

10

Mallios A, Beathard GA, Jennings WC. Early cannulation of percutaneously created arteriovenous hemodialysis fistulae. J Vasc Access. November 2020;21(6):997-1002.

11

Mallios A, Bourquelot P, Harika G, Boura B, Jennings WC. Percutaneous creation of proximal radio-radial arteriovenous hemodialysis fistula before secondary brachial vein elevation. J Vasc Access. March 2021;22(2):238-242.

12

Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M. Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. October 2018;68(4):1150-1156.

13

Mallios A, Nelson PR, Franco G, Jennings WC. Creating percutaneous arteriovenous fistulas at the wrist. J Vasc Access. March 2021;22(2):299-303.

14

Sultan S, Langsfeld M, Chavez L, et al. Initial 6-month quality review of a percutaneous endovascular arteriovenous fistula program. J Vasc Access. July 2021;22(4):540-546.

15

Dawoud D, Lok CE, Waheed U. Recent advances in arteriovenous access creation for hemodialysis: New horizons in dialysis vascular access. Adv Chronic Kidney Dis. May 2020;27(3):191-198.

16

Jones RG, Morgan RA. A Review of the current status of percutaneous endovascular arteriovenous fistula creation for haemodialysis access. Cardiovasc Intervent Radiol. January 2019;42(1):1-9.

17

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.

18

Wee IJY, Yap HY, Tang TY, Chong TT. A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. J Vasc Surg. January 2020;71(1):309-317e5.

19

Wasse H, Alvarez AC, Brouwer-Maier D, et al. Patient selection, education and cannulation of percutaneous arteriovenous fistulae: An ASDIN White Paper. J Vasc Access. November 2020;21(6):810-817.

20

Hull JE, Jennings WC, Cooper RI, Narayan R, Mawla N, Decker M. Long-term results from the pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. J Vasc Interv Radiol. October 2022;33(10):1143-1150.

21

Data on file at Medtronic.

22

Shahverdyan R, Konner K, Matoussevitch V. The past and the future of vascular access surgery: Creation of percutaneous arteriovenous fistula using Ellipsys vascular access system in a patient with previous ipsilateral Scribner-shunt. J Vasc Access. November 2021;22(6):1032-1035.

23

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.

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