Nephrologists

eskd

Nephrologist

Expanding options to address patient needs

av fistula for dialysis

Unique EndoAVF tract

  • Side-to-side anastomoses, like the EndoAVF channel, have been shown to demonstrate more uniform wall shear stress with decreased intensity compared to end-to-side anastomoses.1
  • EndoAVF channel showed minimal vessel trauma with organized, fibrous remodeling in animal study at 31 days post-procedure.2
  • Non-surgical (endovascular) AVF creation uses technology, techniques and imaging systems used by interventionalists, expanding the specialties that can create AVFs.
vascular access for hemodialysis

Vascular/ General Surgeon

vascular access for hemodialysis

Interventional Radiologists

vascular access for hemodialysis

Interventional Nephrologists

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

fistula for dialysis

EndoAVF Opportunities

fistula for dialysis

Limitations of Surgical AVF Creation

Learn more

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

av fistula

Patient Benefits

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

end stage renal disease

Limitations of Surgical AVF creation

AVF is the preferred access for ESKD patients requiring hemodialysis because it can help avoid the high incidence of catheter-related infection and need for surgical revisions associated with AV grafts. Even with advancements in the surgical AVF procedure, the results of surgical AVFs can be suboptimal.

~3.4

Interventions per patient year were needed to maintain a working surgical AVF3

~30%

Patients refused surgical AVF creation or cannulation 4

~3-4

Months’ time to AVF maturation 5

Why Surgical AVFs Fail

Flow limiting lesions often at the site of surgery are associated with maturation failure.

  • In one study, ~30% of surgically-created AVFs were reported to have stenosis at 6-weeks post-op 6
  • Surgical manipulation of the vein is associated with neointimal hyperplasia and primary fistula failure 7,8
vascular access for hemodialysis

Clinical Experience

Data from the EASE (n=32), EASE-2 (n=24), and EUR Post-Market (n=35) studies of WavelinQ™ EndoAVF System were aggregated and analyzed in the 4F Global Analysis (n=91).

Insights

Time to Cannulation >

WavelinQ™ 4F System Pooled Clinical Data (n=91)

Pooled Studies
Median Time to Cannulation, Months1.5 [IQR 1.1,2.0]
Mean Time to Cannulation, Months2 [±1.6]
Time to Cannulation: The interval of time from the index procedure to the first successful 2-needle cannulation of the EndoAVF.
Cannulation Success >
WavelinQ EndoAVFGlobal Data Analysis PDF

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.

arteriovenous fistula

VISUALLY EXPLAINED

Avoids scars and minimizes arm disfigurement associated with open surgery

end stage renal disease
Illustration 1

EndoAVF Creation Site

1
2
3
4

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

Expands Anatomic Options for AVF Creation

Nephrology Resources

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REFERENCES

1
Hull JE, et al. Computational fluid dynamic evaluation of the side-to-side anastomosis for arteriovenous fistula. J Vasc Surg. 2013;58(1):187-193.
2
Results from preclinical study where 4 sheep received percutaneously created fistulae utilizing WavelinQ™ EndoAVF and the tissue healing response was evaluated at 30 ± 2 days. Data on file. GLP Animal Study, using WavelinQ™ 6F EndoAVF System. Preclinical data may not be predictive of actual clinical outcomes. Different tests methods may yield different results.
3
Yang S, et al. Comparison of post-creation procedures and costs between surgical and an endovascular approach to arteriovenous fistula creation. JVA 2017;18:8-4.
4
Xi W, et al. Nephrol Dial Transplant 2011; 26:3302-3308 (Canada population).
5
2017 USRDS annual data report.
6
Cheung et al. J Am Soc Nephrol. 2017 Oct;28(10):3005-3013. Prospective, non-randomized study involving 602 patients.
7
Roy-Chaudhury P, et al. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am soc Nephrol. 2006;17:1112-1127.
8
Bharat A, et al. A novel technique of vascular anastomosis to prevent juxta-anastomotic stenosis following arteriovenous fistula creation. J Vasc Surg. 2012;55(1):274-280.
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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