Why EndoAVF?

The WavelinQ™ 4F EndoAVF System is designed to give you a versatile endovascular AV fistula creation alternative to open surgery. Using two thin, flexible, magnetic catheters and a burst of RF energy you can create an endovascular AV fistula. This transformative technology is delivered with the expert service, support, data, and devices that you expect and deserve, from the leader in AV access.

Surgical Challenges

Surgical AV Fistulas Have Challenges

AVF is the preferred access for ESKD patients requiring dialysis because it avoids the high incidence of catheter-related infection and need for surgical revisions associated with AV grafts. Even with progressions of the surgical AVF procedure, the results of surgical AVFs are still suboptimal.

~3.4

Interventions per year needed to maintain a working AVF1

~30%

Patients refused surgical AVF creation or cannulation2

~3-4

Months time to AVF maturation3

Why Surgical AVFs Fail

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

  • In one study, ~30% AVFs reported stenosis at 6-weeks post-op4
  •  Surgical manipulation of the vein is associated with neointimal hyperplasia and primary fistula failure5,6

Why Surgical AVFs Fail

Patient Benefits

Potential Patient Benefits of EndoAVF

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

Icon clock

Median time to cannulation was 1.5 months [IQR 1.1, 2.0]. Mean time to cannulation was 2.0 (± 1.6) months.7,8

Stat

Avoids surgical scar and minimizes arm disfigurement associated with open surgery

Icon needles

85% (±5.3%) successful cannulation in dialysis subset at 6 months8,9

Icon arm point

Additional anatomic locations for AVF creation10

Patient Impact Arm

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

Cannulation Success: A successful cannulation of the endoAVF with 2-needles for dialysis. A subject may be called a ‘cannulation success’ with the first successful 2-needle cannulation of the endoAVF.

Avoids Scar and Minimizes Arm Disfigurement Associated with Open Surgery

WavelinQ_Why-Endo-AVF_Avoids-Scar-and-Minimizes-Arm-Disfigurement-1-EndoAVF-Creation-Site-02
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
WavelinQ_Why-Endo-AVF_Avoids-Scar-and-Minimizes-Arm-Disfigurement-1-EndoAVF-Creation-Site-02
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

Expands Anatomic Options for AVF Creation

Expands Anatomic Options

*The WavelinQ™ EndoAVF System was supported by a global analysis (“4Fr Global Analysis”) that was designed to aggregate and analyze safety and performance data from the EASE, EASE-2, and EU Study studies of subjects treated with the WavelinQ™ 4F EndoAVF System. See the WavelinQ™ 4F EndoAVF System Instructions for Use for more details on design of the global analysis as well as each study included herein.

Limitations

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); 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.

 

Contraindications

WavelinQ™ 4F EndoAVF System is contraindicated in patients with target creation vessels < 2mm in diameter.

Sign Up For More Information

Learn more about how you can offer more options for your ESKD patients with WavelinQ™ 4F EndoAVF System.

REFERENCES
1 Yang S, et al. JVA 2017; 18(S2): S8-S14.
2 Xi W, et al. Nephrol Dial Transplant 2011; 26:3302-3308 (Canada population).
3 2017 USRDS annual data report.
4 Cheung et al. J Am Soc Nephrol. 2017 Oct;28(10):3005-3013. Prospective, non-randomized study involving 602 patients
5 Roy-Chaudhury et al. JASN 2006;17:1112-27.
6 Bharat et al. JVS 2012;55(1):274-280.
7 Time to Cannulation: the time between the index procedure to the first successful endoAVF cannulation. N=91.
8 Outcomes data was pooled in a Global Data Analysis for 91 subjects enrolled in the three 4 Fr Studies. Data was collected from evaluable patients with sufficient follow-up data for the given time point, excluding patients that experienced unrelated deaths or were lost-to-follow up. N=91.
9 Cumulative cannulation success: Proportion of patients that experienced successful cannulations of the endoAVF with 2-needles for a full dialysis session. Represents evaluable patients at 6 months. Patients were excluded due to lost to follow-up, missed visits and early exits from the study. N=91.
10 The WavelinQ™ 4F 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.