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Important Safety Information

Ellipsys™ vascular access system and IN.PACT™ AV drug-coated balloon

Important safety information

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Ellipsys vascular access system

Contraindications

The Ellipsys™ system is not indicated for patients with target blood vessels that are too small to be used with the Ellipsys™ system.

Warnings

  • The Ellipsys™ system has only been studied for the creation of an arteriovenous fistula (AV Fistula or AVF) using the proximal radial artery and the adjacent perforating vein.
  • The Ellipsys™ system is not intended to treat patients with significant vascular disease or blockage in the target vessels.
  • It is recommended that a follow-up evaluation is performed to determine if any additional treatment is needed.

Precautions

  • Additional treatment may be needed to increase and direct blood flow into the target vein and to keep the AVF open. 
  • Short-term or long-term treatment to slow down or stop the coagulation of blood may be needed, as determined by your doctor. 

Potential Adverse Events

As with any procedure, there is a chance that complications may occur. The following are some of the risks that may be associated with the creation or maintenance of your arteriovenous fistula. Discuss any questions you may have with your doctor.

Risks include but are not limited to the following:

  • Total blockage, partial blockage or narrowing of the fistula or outflow vein next to the fistula
  • Narrowing of the central AVF outflow vein which requires treatment
  • Vein may not get big enough, after the AVF is created
  • If embolization coil is used to direct blood flow, the coil may not completely tie off the vessels, which could require an additional coil
  • Lack of blood flow to the hand (Steal Syndrome), which can cause symptoms including but not limited to: hand numbness, pain, coldness, and/or weakness
  • Solid swelling of clotted blood within the arm
  • Infection or other complications
  • Need for additional procedures to help access the AVF for dialysis
  • Need for additional procedures to help the vein get bigger after the AVF is created

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.

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IN.PACT AV drug-coated balloon

Potential Adverse Effects Associated with the IN.PACT AV DCB

Potential adverse effects that may be associated with balloon catheterization may include, but are not limited to, the following:

  • Abrupt vessel closure
  • Allergic reaction
  • Arrhythmias
  • Arterial or venous aneurysm
  • Arterial or venous thrombosis
  • Death
  • Dissection
  • Embolization
  • Hematoma
  • Hemorrhage
  • Hypotension/hypertension
  • Ischemia or infarction of tissue/organ
  • Infection
  • Loss of permanent access
  • Pain
  • Perforation or rupture of the artery or vein
  • Pseudoaneurysm
  • Restenosis of the dilated vessel
  • Shock
  • Stroke
  • Vessel spasms or recoil

Although systemic effects are not anticipated, potential adverse effects that may be unique to the Paclitaxel drug coating include, but are not limited to, the following:

  • Allergic/immunologic reaction
  • Alopecia
  • Anemia
  • Gastrointestinal symptoms
  • Hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia)
  • Hepatic enzyme changes
  • Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis
  • Myalgia/arthralgia
  • Myelosuppression
  • Peripheral neuropathy

IN.PACT AV: Summary of Clinical Information

The IN.PACT AV drug-coated balloon was evaluated in the IN.PACT AV Access Study. The IN.PACT AV Access Study enrolled 330 patients in the United States, Japan, and New Zealand. The clinical trial conclusively demonstrated safety and effectiveness of the IN.PACT AV DCB when compared to conventional balloon catheters. The results of this study showed that the IN.PACT AV DCB is safe and effective for treating restenotic obstructive lesions of an AV both de novo and restenotic obstructive lesions. Your doctor can explain the risks and benefits that are specific to you.

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UC202405894 EN

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Ellipsys Vascular Access System

Kidney treatments & therapies

Ellipsys™ vascular access system

Less invasive, long-lasting. The Ellipsys system offers a less-invasive approach to create an arteriovenous (AV) fistula for hemodialysis.1,2

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Alert Important Safety Information

Meet the Ellipsys system.

The Ellipsys vascular access system offers a fast, nonsurgical approach to AV fistula creation, using heat to fuse the artery and vein together during a procedure that usually takes 30 minutes or less.2

What is an AV fistula?

To perform hemodialysis, the doctor needs a way to safely and repeatedly access your bloodstream. This point of access allows your blood to be cleaned by a dialysis machine and then returned to you. The most common access point for hemodialysis is an arteriovenous (AV) fistula. If your doctor recommends this option, it is important to know there are two ways to create an AV fistula.

Surgical

  • The most common option
  • Connects the artery and vein with sutures during an outpatient surgery
  • Usually takes an hour or more to perform3
  • Requires an open incision that leaves a scar

Nonsurgical (Ellipsys system)

  • More recent option
  • Connects an artery and vein with heat during a minimally invasive procedure
  • Procedure usually takes 30 minutes or less2
  • Does not require an incision or sutures — only a small needle stick
  • May place less stress on the heart compared to a traditional upper-arm surgical fistula4
Illustration of an arm showing veins, arteries, and the AV fistula with numbered callouts
  1. Vein
  2. Artery
  3. AV fistula

Using the Ellipsys system, 98.4% of patients have a working fistula at three months2

Using the Ellipsys system, 92% of patients have a working fistula at five years5

This procedure is not for everyone. Please talk to your doctor to see if it is right for you. 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. Although many patients benefit from the use of this device, results may vary. Your doctor should discuss all terms, potential benefits, and risks with you.

What is the Ellipsys experience like?

Getting a nonsurgical AV fistula with the Ellipsys system follows four stages.

1. Selection

A simple in-office test (ultrasound imaging) can determine if you are a good candidate for an endovascular AV fistula.

2. Creation

The minimally invasive procedure using the Ellipsys system usually takes 30 minutes or less to perform.2

3. Maturation

Follow-ups over a six-week period help establish if the AV fistula is mature enough to support hemodialysis.

4. Cannulation

Cannulation occurs when the AV fistula is ready to allow regular hemodialysis.

What happens during a procedure using the Ellipsys system?

There are six steps in the procedure:

1. Venous puncture
 

Illustration of Ellipsys™ system about to puncture a vein

2. Radial artery puncture
 

Illustration of Ellipsys™ system puncturing the radial artery vein

3. Catheter positioning and activation

Illustration of Ellipsys™ system being positioned and activated

4. Balloon inflation

Illustration of Ellipsys™ system balloon inflating

5. Fistula created

Illustration of Ellipsys™ system showing fistula creation

6. Post-op bandage

Illustration of an arm with a bandage on it

Start the conversation.

Our doctor discussion guide can help you talk about treatment options with your doctor.

Get the guide
Older male patient in blue shirt sitting next to a female physician in white coat as they look at a clipboard while smiling

References

1

Shahverdyan R, Beathard G, Mushtaq N, et al. Comparison of Ellipsys Percutaneous and Proximal Forearm Gracz-Type Surgical Arteriovenous Fistulas. Am J Kidney Dis. October 2021;78(4):520–529.e1.

2

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.

3

Arteriovenous Fistula (AV Fistula). University of Utah Health. Available at: https://healthcare.utah.edu/cardiovascular/treatments/arteriovenous-fistula. Accessed October 5, 2023.

4

Mallios A, Bourquelot P, Franco G, et al. Mid-term 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

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. October 2022;33(10):1143–1150.

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