The Non-Surgical

AV Fistula Creation Option

The First Major Advancement in AV Fistula Creation in Over 50 Years

ENDOAVF – NEW OPTION

More Options for Patients with End Stage Kidney Disease (ESKD)

Worldwide, 2 million people with ESKD receive hemodialysis therapy and require vascular access to connect their blood circulation to a dialysis machine. AV fistulas are the preferred approach to achieve vascular access and until recently, they have required an open surgical procedure for creation.

The WavelinQ™ EndoAVF System is designed to create an endovascular AV fistula (endoAVF) for hemodialysis access in patients who have chronic kidney disease and need dialysis, using a completely endovascular approach in vessels that are not traditionally used during open surgery.

Patients must meet certain anatomical characteristics that support the use of the WavelinQ™ EndoAVF procedure. Patients should consult their physician to determine if they are a candidate for an endoAVF procedure.

Rethink fistula creation with non-surgical WavelinQ system for vascular access for hemodialysis

Why EndoAVF?

The WavelinQ™ EndoAVF System is designed to give you a versatile endovascular AV fistula creation alternative to open surgery.

Avoids surgical scarring and minimizes arm disfigurement associated with open surgery
Additional anatomical AV fistula locations
Multiple venous procedural approaches¹¹

Limitations of Surgical AVF Creation

While AV fistulas are the preferred access option for ESKD patients, surgical creation has challenges.

Patient Benefits

EndoAVF offers patients potential benefits compared to current surgical creation options.

Our product

The WavelinQ™ EndoAVF System consists of a 4F venous and a 4F arterial magnetic catheter. It is used with an electrosurgical unit (radiofrequency generator), ground pad, and an electrosurgical pencil.

WavelinQ EndoAVF system vascular access for hemodialysis

WavelinQ EndoAVF - vascular access for hemodialysis

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THE STEPS

How It Works

The catheters are each inserted into an artery and a vein in the arm through a small puncture or incision. Using fluoroscopy, the catheters are advanced to the appropriate location for the creation of an endovascular AV fistula. 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.

1 Step

Access

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

2 Step

Alignment

When placed in proximity, the magnets in each catheter attract to each other, pulling the vessels together and aligning the RF electrode.

3 Step

Activation

The venous catheter, which contains the electrode, delivers a burst of RF energy to create a connection between the artery and vein. Then, the catheters are removed.

4 Step

Completion

A brachial vein embolization is then recommended to divert more flow through the perforator to the superficial veins (cephalic, median cubital and/or basilic veins) for hemodialysis.

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Learn more about how you can offer more options for your patients with ESKD with the WavelinQ™ EndoAVF System.

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WavelinQ^TM

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

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.
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.
Use caution when performing electrosurgery in the presence of pacemakers.
Improper use could damage insulation that may result in injury to the patient or operating room personnel.
Do not plug devie into the electrosurgical pencil with ESU on.
Keep active accessories away frompatientwhen not in use.
Do not permit cable to be parallel to and/or in close proximity to leads of other devices.
Do not warp cable around handles or metallic objects such as hemostats.
Consult the ESU User's Guide on its proper operation prior to use.
Do not use closure devices not indicated to close the artery used for access.

Cautions

Only physicians trained and experienced in endovascular techniques should use the device.
Adhere to universal precautions when utilizing the device..
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.
Avoid sharp bends. This may cause the device to become inoperable.
Do not pinch or grasp the catheter with excessive force or with other instruments
Do not bend the rigid portion of the catheter near the electrode or backstop.
Do not touch or handle the active electrode. Electrode dislodgement may occur.
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.
Do not attempt to remove the hemostasis valve crosser located on the venous device. Device damage or fracture may occur.

Precautions

Care should be taken to avoid the presence of fluid on the ESU.
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.
Care should be taken to avoid attempting fistula creation in a heavily calcified location of a vessel as fistula may not be adequately formed.
The safety and performance of this device has not been established for pediatric patients.
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.
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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