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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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Contact & Support

Managing CKD

Kidney conditions

Managing chronic kidney disease

Understand all the steps you can take to help manage your condition today and tomorrow.

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Alert Important Safety Information

Measuring kidney function

To understand how well your kidneys are working, your doctor looks at your glomerular filtration rate (GFR), which measures how well your kidneys are working.1 This number helps detect and diagnose CKD, track its progression over time, and make decisions about your treatment plan.

Measuring GFR precisely requires a complex and time-consuming procedure. Typically, your doctor will determine an estimated GFR (eGFR) by combining your age, sex, body type, and race.1

How your condition is progressing depends on your eGFR, as well as urine tests and risk factors.1

GFR category1

GFR level1

Description1

GI

≥ 90

Normal

G2

60–89

Mildly decreased

G3a

45–59

Mildly to moderately decreased

G3b

30–44

Moderately to severely decreased

G4

15–29

Severely decreased

G5

< 15

Kidney failure

Potential complications

It’s important to be aware of how CKD can affect your body over time. Potential complications of CKD may include fluid retention and swelling, heart disease, anemia, and a lowered immune response. Not everyone experiences these complications. 

If complications do occur, treatments are available. They include2:

  • Medications to lower blood pressure
  • Medications to relieve swelling (diuretics)
  • Medications for anemia and fatigue (erythropoietin)
  • Medications to reduce cholesterol (statins)
  • Medications to protect bones (calcium and vitamin D)
  • Lower-protein diet to minimize waste products in the blood

Ultimately, you may need dialysis or a kidney transplant.

Explore treatment options

Slowing the progress of CKD

Fortunately, healthy lifestyle choices may be able to slow the progress of your condition. These choices help prevent your kidneys from working too hard.3

  • Healthy weight
  • Daily activity
  • Balanced, low-sodium diet
  • Controlled blood pressure
  • Annual cholesterol check
  • Controlled blood sugar
  • No smoking
  • Regular checkups
Older couple ride bicycles in leaves within a circle on a transparent background

Overcoming the challenges of CKD

Living with CKD can be difficult. The good news is there are many kinds of support available during your journey. Here are a few steps you can take to get the support you need.

Reduce stress.

Staying active is always a good option. You may also want to try medication or simply enjoying your favorite music, podcasts, books, and movies.

Ask for help.

If you start to feel overwhelmed, reach out. Talk to a trusted friend or family member or a mental health professional.

Talk to peers.

You’re not alone on your journey. Join a CKD support group or talk to someone who has been living with CKD through the NKF Peers Program.

Stay in touch.

Regular checkups with your doctor and kidney specialist (nephrologist) will help you understand what stage you are in and what to do next.

References

1

Blood test: eGFR (estimated glomerular filtration rate). American Kidney Fund. Available at: https://www.kidneyfund.org/all-about-kidneys/tests/blood-test-egfr#. Accessed on October 31, 2023.

2

Chronic kidney disease: Diagnosis & treatment. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/diagnosis-treatment/drc-20354527. Accessed on October 31, 2023.

3

End-stage renal disease: Symptoms & causes. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/end-stage-renal-disease/symptoms-causes/syc-20354532. Accessed on October 31, 2023.

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