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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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IN.PACT AV Drug-coated Balloon

Kidney treatments & therapies

IN.PACT™ AV drug-coated balloon (DCB)

A treatment option for people on dialysis with an AV fistula

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Alert Important Safety Information

Proactive treatment, fewer interruptions

The IN.PACT AV drug-coated balloon (DCB) gives people on dialysis a proactive treatment option for fistula maintenance.

What if you could reduce the number of procedures you need to keep your fistula open?

An arteriovenous (AV) fistula provides a critical lifeline during dialysis treatment. But keeping it open may require as many as three fistula maintenance procedures every year.1 You may be able to reduce this total with a more effective, longer-lasting treatment: the Medtronic IN.PACT AV drug-coated balloon.2

Treatment with the IN.PACT AV DCB is prescribed by your doctor. This treatment is not for everyone.

Please talk to your doctor to see if it is right for you. Your doctor should discuss all potential benefits and risks with you. Risks may include pain, hemorrhage, arterial or venous aneurysm/thrombosis, dissection, infection, perforation or rupture, death. Although many patients benefit from the use of this treatment, results may vary.

56% fewer fistula procedures
through six months for people treated with the Medtronic IN.PACT AV drug-coated balloon.*2

*Compared to traditional angioplasty balloons.

What is a maintenance procedure?

One of the most common issues with fistulas is narrowing, which can happen when your body sends extra cells to “repair” the fistula. These cells build up over time, slowing blood flow and making dialysis less effective. If this happens, you may need a maintenance procedure to treat it.

There are several minimally invasive (nonsurgical) options doctors use to open a narrowed fistula. Two of the most common include:

Electric blue illustration of a drug-coated balloon

Traditional balloon

During this procedure, an inflatable balloon is placed into the fistula through a small tube (catheter). The balloon is inflated in the narrowed section of the fistula to open it back up again. Then the balloon is deflated and removed.

Electric blue illustration of an inflatable drug-coated balloon

Drug-coated balloon

A drug-coated balloon uses the same procedure as a traditional angioplasty balloon, but with one important difference. This balloon is coated with a specialized drug called paclitaxel that can help delay the re-narrowing of your fistula in the future. So it not only widens the fistula, it also helps keep it open longer.

What can I expect before my procedure?

The IN.PACT AV DCB procedure is performed in a hospital or clinic. Your doctor will first access the fistula through a catheter and take X-rays of your blood vessels (also called angiograms) to confirm it is narrowed and needs maintenance.

What happens during my procedure?

During the procedure, your doctor will:

Illustration of the IN.PACT™ AV DCB procedure showing the placement of the guidewire into the fistula

Place a traditional angioplasty balloon over a guidewire into your fistula.

Illustration of the IN.PACT™ AV DCB procedure showing the inflated traditional balloon in the fistula

Inflate and deflate the balloon to open up your fistula.

Illustration of the IN.PACT™ AV DCB procedure showing the open fistula

Remove the traditional angioplasty balloon, leaving the vessel prepared for the IN.PACT AV DCB.

Illustration of the IN.PACT™ AV DCB procedure showing the IN.PACT™ AV balloon inflated in the fistula delivering medication

Place the IN.PACT AV DCB in the same location and inflate it to deliver the drug.

Illustration of the IN.PACT™ AV DCB procedure showing the open fistula

Deflate the IN.PACT AV DCB and remove it.

What happens after my procedure?

Once the procedure is complete, light pressure is placed on the small hole where the needle was inserted. This will help to stop any bleeding. An adhesive bandage or small suture will be placed at the site, and you will be moved to a recovery area.

The puncture site may be sore or bruised after the procedure, but typically will feel better in a few days. Watch for bleeding, swelling, pain, or discomfort at the puncture site. If you experience any of these symptoms, tell your doctor.

Hear Dominic’s story.

Watch Dominic’s story to learn more about IN.PACT AV DCB and how it can help maintain access to critical dialysis.

Talk to your care team.

Ask your care team if the Medtronic IN.PACT AV drug-coated balloon could minimize your maintenance procedures and help you experience longer periods of uninterrupted dialysis.

Your doctor will decide what is best, but may not recommend DCB treatment if any of the following are true:

Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy.

Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.

Patients with known allergies or sensitivities to paclitaxel.

Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reactions in nursing infants from paclitaxel exposure.

Start the conversation.

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

Get the guide
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References

1

United States Renal Data System. 2022 USRDS annual data report.

2

Lookstein RA, Haruguchi H, Ouriel K, et al. IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. August 20, 2020; 383(8):733–742. 

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