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The Ellipsys vascular access system is a unique single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula.1
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 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 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
Learn how to optimize the entire care continuum for endovascular AVF creation including patient selection, fistula creation, maturation, and cannulation.
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
No surgery, sutures, surgical scar, or implant
Lower risk of cannulation segment aneurysms3,4
Candidate patients may include up to 65% of the general ESKD population1,2,6,9,17,23
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.
Get resources to assist coding, coverage, and reimbursement for the Ellipsys system.
Compared to surgical arteriovenous fistulas.
Device class is endovascular arteriovenous fistula.
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.
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.
Beathard GA, Litchfield T, Jennings W. Two-year cumulative patency of endovascular arteriovenous fistula. J Vasc Access. May 2020;21(3):350-356.
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.
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.
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.
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.
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.
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.
Mallios A, Beathard GA, Jennings WC. Early cannulation of percutaneously created arteriovenous hemodialysis fistulae. J Vasc Access. November 2020;21(6):997-1002.
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.
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.
Mallios A, Nelson PR, Franco G, Jennings WC. Creating percutaneous arteriovenous fistulas at the wrist. J Vasc Access. March 2021;22(2):299-303.
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.
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.
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.
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.
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.
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.
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.
Data on file at Medtronic.
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.
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.