Nephrologist

Since entering the US market in 2018, endovascular fistula creation has offered patients and clinicians an alternative to surgical AV fistula creation. WavelinQ™ EndoAVF System is designed to provide a versatile, minimally invasive option for ESKD patients.

Expanding options to address patient needs

Infographic

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.

 

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.

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

 

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

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

Time to Cannulation: The interval of time from the index procedure to the first successful 2-needle cannulation of the endoAVF.

Clinical Data

Cannulation Success (Dialysis subset): Successful 2-needle cannulation and dialyis though the endoAVF.

*This includes subjects who were enrolled on hemodialysis or initiated hemodialysis at any point in the follow up.

Patient Benefits

EndoAVF provides a non-surgical AV fistula creation option, offering a variety of potential patient benefits.

Stat

Avoids surgical scar and minimizes arm disfigurement associated with open surgery

Stat

Additional anatomic locations for AVF creation 9

Stat

Can be created with local or regional anesthesia

POTENTIAL ADVERSE EVENTS ASSOCIATED WITH WAVELINQ™ ENDOAVF SYSTEM

Potential adverse events include: aborted (terminated) or longer procedure; additional procedures; bleeding, hematoma (bruise) or hemorrhage (bleeding); bruising; burns; death; electrocution; embolism (occlusion/blockage of vessels); failure to mature; fever; increased risk of congestive heart failure; infection; numbness, tingling, and/or coolness; occlusion/stenosis (blockage/narrowing); problem due to sedation or anesthesia; pseudoaneurysm (false swelling); aneurysm, sepsis (infection); steal syndrome or ischemia (not enough blood flow); swelling, irritation, or pain; thrombosis (clotting); toxic or allergic reaction; venous hypertension (arm swelling); vessel, nerve, or AVF damage or rupture; wound problem.

Avoids Scars and Minimizes Arm Disfigurement Associated with Open Surgery

EndoAVF Creation Site
EndoAVF Creation Site
At 1st Cannulation
At 1st Cannulation
At ~1 Year Post-Op
At ~1 Year Post-Op
At ~2.5 Years Post-Op
At ~2.5 Years Post-Op
EndoAVF Creation Site
EndoAVF Creation Site
At 1st Cannulation
At 1st Cannulation
At ~1 Year Post-Op
At ~1 Year Post-Op
At ~2.5 Years Post-Op
At ~2.5 Years Post-Op

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

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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.
9 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.