High Procedure Technical Success & Patency

Summary: 97% Procedure technical success

Procedural Success: was defined as the successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or postoperative duplex ultrasonography.

Primary Patency at 6 months: 72.4% (±5.2%)

The interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis, access abandonment, or the time of measurement of patency.

Secondary Patency at 6 months: 77.3% (±5%)

The interval from the time of access placement until access abandonment, lost to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access.

Primary, Assisted Primary, and Secondary Patency: were defined according to the Society of Vascular Surgery (SVS) reporting standards. Rates were determined using the K-M point estimates at month 6. The SVS reporting standards advocate K-M curves to estimate patency.

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REFERENCES

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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.

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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