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:
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.
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:
Place a traditional angioplasty balloon over a guidewire into your fistula.
Inflate and deflate the balloon to open up your fistula.
Remove the traditional angioplasty balloon, leaving the vessel prepared for the IN.PACT AV DCB.
Place the IN.PACT AV DCB in the same location and inflate it to deliver the drug.
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.
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.