What is EndoAVF?

av fistula for dialysis

What is EndoAVF?

When you have end-stage kidney disease (ESKD), your kidneys can no longer keep up with your body’s need to remove extra waste and water.

In fact, once your kidneys only have 10-15% of normal function, dialysis treatments or a kidney transplant are necessary to sustain life.1

When it comes to creating access to your bloodstream to administer hemodialysis, there are several access options. Your access options may vary greatly depending on your condition.

Keep in mind, risks with all ESKD access options should be discussed with your physician.

Arteriovenous Fistula (AVF)

AV fistulas can be created in your wrist, forearm, inner elbow or upper arm. Your AVF can be created either with an open surgery (surgical AVF) or with a minimally invasive procedure (endoAVF). WavelinQ™ EndoAVFs are created in the upper forearm. While maturation varies, some AV fistulas are able to function for many years.

Patients who may benefit from an EndoAVF are patients with chronic kidney disease who need hemodialysis. In addition, a patient must meet certain anatomical characteristics that support the use of the WavelinQ™ EndoAVF System procedure. Patients should consult their physician to determine if they are a candidate for an EndoAVF procedure.

Two thin devices create a connection between your vein and artery without the need for open surgery. The devices are removed from the body once the connection is created.

Procedural Overview

WavelinQ™ EndoAVF vs. Surgical AVF

WavelinQ™ EndoAVF

Two thin devices create a connection between your vein and artery without the need for open surgery. The devices are removed from the body once the connection is created.

Surgical AVF

A surgeon dissects one of your veins with a scalpel and sews it to one of your arteries during an open surgery.

av fistula

STEP 1

The doctor inserts two thin devices into the artery and the vein through small needle punctures.

arteriovenous fistula

STEP 1

A surgical cut is made with a scalpel.

end stage renal disease

Step 2

Magnets align the devices and a connection is made between the vein and artery in the forearm. The doctor then removes the devices.

fistula for dialysis

Step 2

A vein is dissected, moved, and sewn into an artery.

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STEP 3

The arm heals without stitches with little to no scarring.

av fistula for dialysis

STEP 3

The surgical wound is stitched closed and heals over the next few weeks.

Post-Procedure Steps

WavelinQ™ EndoAVF

  • The small needle punctures heal quickly with minimal need for wound care.
  • Additional procedures may be needed to prepare the EndoAVF for hemodialysis.
  • Follow-up visits will be required over the next few weeks to determine when the AVF is ready for hemodialysis.

Surgical AVF

  • The small needle punctures heal quickly with minimal need for wound care. Your healthcare provider will give you detailed instructions on how to care for your surgical wound.
  • Literature suggests that it is common that two or more procedures are required to make surgical AVFs ready for and to maintain hemodialysis access.
  • Follow-up visits will be required over the next few weeks to determine when the AVF is ready for hemodialysis.

Patient benefits

EndoAVF provides a non-surgical AV fistula creation option, offering potential benefits compared to surgical AV fistula creation.

arteriovenous fistula

Avoid scars

Avoids surgical scar and minimizes arm disfigurement associated with open surgery

end stage renal disease

Additional locations

Additional anatomic locations for AVF creation 9

fistula for dialysis

Under regional anesthesia

Can be created with local or regional anesthesia

Potential adverse events associated with the WavelinQTM EndoAVF system

The known potential risks related to the WavelinQ™ EndoAVF System and procedure, a standard AVF, and endovascular procedures may include, but are not limited to: aborted or longer procedure; additional procedures; bleeding, hematoma, or hemorrhage; bruising; burns; death; electrocution; embolism; failure to mature; fever; increased risk of congestive heart failure; infection; numbness, tingling, and/or coolness; occlusion/stenosis; problem due to sedation or anesthesia; pseudoaneurysm; aneurysm; sepsis; steal syndrome or ischemia; swelling, irritation, or pain; thrombosis; toxic or allergic reaction; venous hypertension (arm swelling); vessel, nerve, or AVF damage or rupture; wound problem.

end stage kidney disease

VISUALLY EXPLAINED

Avoids scars and minimizes arm disfigurement associated with open surgery

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Illustration 1

EndoAVF Creation Site

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Individual patient outcomes can and do vary based on the condition of the patient, severity of disease, extent of surgery, and response to treatment.

Patient Resources

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REFERENCES

1
A to Z Health Guide, Hemodialysis. National Kidney Foundation, 2019. https://www.kidney.org/atoz/content/hemodialysis.
2
The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.
WavelinQTM

Indications

The WavelinQ™ EndoAVF System is intended for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula used for hemodialysis.

Contraindications

  • Known central venous stenosis or upper extremity venous occlusion on the same side as the planned AVF creation. procedure. procedure.
  • Known allergy or reaction to any drugs/fluids used in this procedure.
  • Known adverse effets tomoderatesedation and/or anesthesia.
  • Distance between target artery and wein > 1.5mm.
  • Target wessels 2mm in diameter.

Warnings, Cautions, and Precautions

Warnings

  1. The WavelinQ™ EndoAVF System is only to be used with the approved commercially available devices specified above. Do not attempt to substitute non-approved devices or use any component of this system with any other medical device system.
  2. The WavelinQ™ catheters are single use devices. DO NOT re-sterilize or re-use either catheter. Potential hazards of reuse include infection, device mechanical failure, or electrical failure, potentially resulting in serioys injury or death.
  3. Use caution when performing electrosurgery in the presence of pacemakers.
  4. Improper use could damage insulation that may result in injury to the patient or operating room personnel.
  5. Do not plug devie into the electrosurgical pencil with ESU on.
  6. Keep active accessories away frompatientwhen not in use.
  7. Do not permit cable to be parallel to and/or in close proximity to leads of other devices.
  8. Do not warp cable around handles or metallic objects such as hemostats.
  9. Consult the ESU User's Guide on its proper operation prior to use.
  10. Do not use closure devices not indicated to close the artery used for access.

Cautions

  1. Only physicians trained and experienced in endovascular techniques should use the device.
  2. Adhere to universal precautions when utilizing the device..
  3. Do not kink, pinch, cut, bend, twist, or pull excessively or with excessive force on any portion of the devices. Damage to the catheter body may cause the device to become inoperable.
  4. Avoid sharp bends. This may cause the device to become inoperable.
  5. Do not pinch or grasp the catheter with excessive force or with other instruments
  6. Do not bend the rigid portion of the catheter near the electrode or backstop.
  7. Do not touch or handle the active electrode. Electrode dislodgement may occur.
  8. Always use the hemostasis valve crosser to assist insertion of the venous catheter through the introducer sheath. Insertion into introducer sheath without hemostasis valve crosser may damage electrode.
  9. Do not attempt to remove the hemostasis valve crosser located on the venous device. Device damage or fracture may occur.

Precautions

  1. Care should be taken to avoid the presence of fluid on the ESU.
  2. Care should be taken during handling of the arterial and venous catheters in patients with implantable cardiac defibrillators or cardiac pacemakers to keep the distal 3 inches of the catheters at least 2 inches from the implanted defibrillator or pacemaker.
  3. Care should be taken to avoid attempting fistula creation in a heavily calcified location of a vessel as fistula may not be adequately formed.
  4. The safety and performance of this device has not been established for pediatric patients.
  5. If the device does not perform properly during the creation of the endovascular fistula it is possible that a fistula will not be created or there may be some vessel injury.
  6. Keep magnetic ends of catheters away from other metallic objects which may become attracted and collide with devices.

Electrical Safety

The WavelinQ™ EndoAVF System complies with the electrical safety standards 60601-1, 60601-1-2 and 60601-2-2.

Potential Adverse Events

The known potential risks related to the WavelinQ™ EndoAVF System and procedure, a standard AVF, and endovascular procedures may include, but are not limited to: aborted or longer procedure; additional procedures; bleeding, hematoma or hemorrhage; bruising; burns; death; electrocution; embolism; failure to mature; fever; increased risk of congestive heart failure; infection; numbness, tingling, and/or coolness; occlusion/stenosis; problem due to sedation or anesthesia; pseudoaneurysm; aneurysm; sepsis; steal syndrome or ischemia; swelling, irritation, or pain; thrombosis; toxic or allergic reaction; venous hypertension (arm swelling); vessel, nerve, or AVF damage or rupture; wound problem.

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