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September 10, 2020

Study Compares Avenu Ellipsys Access System and BD WavelinQ for pAVF Creation

September 10, 2020—Avenu Medical announced the publication of a study comparing the company’s Ellipsys vascular access system and the WavelinQ 4-F system (BD Interventional) for percutaneous arteriovenous fistula (pAVF) in patients with end-stage renal disease. Robert Shahverdyan, MD, et al published the study in Journal of Vascular and Interventional Radiology (JVIR; 2020;31:1365-1372).

The single-center study, led by Dr. Shahverdyan at Vascular Access Center in Hamburg, Germany, compared the outcomes for 100 patients who underwent pAVF procedures (65 Ellipsys and 35 WavelinQ) from December 2017 to December 2019.

According to Avenu Medical, the investigators found that both devices demonstrated high rates of technical success and low rates of complications. Both devices also allowed patients to start dialysis sooner compared with surgery, providing significant quality-of-life benefits.

The technical success rate and percentage of patients who required secondary interventions after fistula creation was 100% and 27.7% for the Ellipsys system versus 97% and 26.5% for the WavelinQ system. However, 79.5% of Ellipsys patients were able to successfully begin dialysis with their fistula, compared with 58% of WavelinQ patients. Additionally, 82% of Ellipsys fistulas were still functional at 12 months versus 60% of WavelinQ fistulas.

Compared to surgical fistulas, both devices reduced the time to dialysis. The mean time to cannulation was 60 days with Ellipsys versus 90 days for WavelinQ.

Dr. Shahverdyan noted that 75% of Ellipsys fistulas were ready for cannulation at 4 weeks, with a small number of patients ready for early cannulation within a few days of fistula creation.

“For every patient, my goal is to create the best possible dialysis access with the fewest possible interventions,” commented Dr. Shahverdyan in Avenu’s press release. “Our data show that with careful planning, both systems can safely and quickly create percutaneous fistulas with a high rate of success, though the Ellipsys system appears to create more durable access that is also easier to repair if that becomes necessary.”

Jeffrey Hull, MD, an interventional radiologist and Director of the Richmond Vascular Center in North Chesterfield, Virginia, added, “This study confirms other newly published data showing how much faster we can start using the Ellipsys percutaneous fistula for dialysis—a finding that has significant patient safety benefits. The sooner a patient can start dialysis with their fistula, the sooner we can get them off such riskier dialysis access methods as central venous catheters, which are associated with much higher rates of infection and other complications.” Dr. Hull is founder and consultant to Avenu Medical.

In JVIR, Dr. Hull recently published a study of Ellipsys pAVF that reported an average time to dialysis of 66 days. Alexandros Mallios, MD, recently published a study in Journal of Vascular Surgery showing that patients were able to begin using their pAVF for dialysis an average of 4 weeks after creation, with 6% of fistulas becoming functional in as short as 2 weeks.

Avenu Medical noted that the single-catheter Ellipsys system uses ultrasound guidance and thermal energy to create the fused and permanent connection between the perforating vein and the proximal radial artery; no radiation or contrast media are required. The WavelinQ device is a two-catheter system that uses radiofrequency energy and fluoroscopy to create an aligned slit fistula. Differences between the systems can affect patient eligibility for the procedures based on anatomic constraints, according to the company.

Dr. Shahverdyan concluded in the press release, “Based on our preoperative ultrasound evaluations, we found that 65% of patients were eligible for an Ellipsys pAVF, compared to just 27% with the WavelinQ system. By knowing that more than twice as many patients will be able to undergo the procedure, Ellipsys makes it more feasible for a center to offer this endovascular approach to creating dialysis access.”

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