Proceduralist

hemodialysis fistula

Proceduralist

The WavelinQ™ EndoAVF System offers physicians a non-surgical alternative for AV fistula creation. Using two thin, flexible, magnetic catheters and a burst of RF energy, proceduralists can create an endovascular AV fistula.

av fistula for dialysis

Indications

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

How It Works

The catheters are each inserted into an artery (brachial) and a vein (brachial, ulnar or radial) in the arm through a small puncture or incision. Using fluoroscopy, the catheters are both advanced to the appropriate location for endovascular AV fistula creation (ulnar artery-ulnar vein or radial artery-radial vein). The magnets in the catheters allow them to be precisely aligned while pulling the two adjacent vessels closer together. The venous catheter, which contains the electrode, delivers a burst of RF energy to create a connection between the artery and the vein.

av fistula for dialysis

The steps

How it works

av fistula surgery
1 Step

Access

Two thin, flexible, magnetic catheters are inserted into an artery and vein in the arm through small punctures or incisions.

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Clinical Experience

Clinical studies of WavelinQ™ EndoAVF System evaluated safety and effectiveness of the device. Below are the findings from the studies.

Insight

Low Device and Procedure Related SAE >

Device-Related SAE1:

Procedure-Related SAE2:

3.3%5.5%

(3/91)

(5/91)

SAE: Serious Adverse Event as adjudicated by the CEC, reported at any time during follow-up.3
High Procedure Technical Success >
Low interventions >

Read the global data analysis

eskdGlobal data analysis PDF

1,2Data from the EASE (n=32), EASE-2 (n=24) and the EUR Post-Market (n=35) studies of the WavelinQ™ 4F EndoAVF System was aggregated and analyzed in the 4F Global Analysis (n=91). See the WavelinQ™ EndoAVF System Instructions for Use for the full analysis, including more details on each of the studies.

3BD data on file. Clinical Study Report

Training and Support

ADVANCE>

A clinical training & education program

Professional Ultrasound Training

Our specialized endovascular fistula teams help educate and train the ultrasound team on vein mapping for WavelinQ™ EndoAVF.
vascular access for hemodialysis

Hands-on Physician Training

Our expert physician trainers conduct procedural training using a mix of the virtual technologies, simulators and hands-on demonstrations and our local certified specialists in-service the full procedure team, proctor initial cases and follow up.
vascular access for hemodialysis

EndoAVF Cannulation Training

Our specialized dialysis team helps prepare dialysis centers for endoAVF cannulation.
vascular access for hemodialysis

Procedural Resources

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REFERENCES

1
Device-Related SAE: Adverse Event related to study device.
2
Procedure-Related SAE: Adverse Event that occurred during index procedure.
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Serious Adverse Events (SAE): If an event results in the following, it is automatically an SAE: Led to a death; or
  • Led to serious deterioration in the health of the subject, that either resulted in:
    • A life-threatening illness or injury;
    • A permanent impairment of a body structure or a body function;
    • Inpatient or prolonged existing hospitalization;
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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