September 3, 2020
Study Shows Avenu Medical’s Ellipsys endoAVF System Reduces Time to Dialysis
September 3, 2020—Richmond Vascular Center in North Chesterfield, Virginia, announced the publication of a study demonstrating that the Ellipsys vascular access system (Avenu Medical, Inc.) reduces the time before patients with kidney failure can begin dialysis treatments while requiring fewer secondary procedures. The announcement noted that this could have a significant impact on patient safety and health care costs by reducing the need for other forms of dialysis access that are associated with higher rates of complications.
The article was published by Jeffrey Hull, MD, John Deitrick, MD, and Karey Groome, NP-C, in Journal of Vascular & Interventional Radiology (2020;31:1371-1381). Dr. Hull, an interventional radiologist and Director of the Richmond Vascular Center, is founder and consultant to Avenu Medical.
Ellipsys, which uses a small needle puncture and catheter to create an endovascular arteriovenous fistula (endoAVF), was cleared by the FDA in 2018 for patients with end-stage kidney disease.
The prospective study was composed of 123 patients at Richmond Vascular Center. The investigators evaluated patient selection and best practices for preparing (“maturing”) Ellipsys fistulas for dialysis. The results showed that the use of the Ellipsys system along with early maturation procedures reduced the average time from fistula creation to dialysis to 66 days, down from 100 days in the initial United States pivotal trial. This compares to literature in the United States reporting that the time to dialysis with surgical fistulas averages 135 days.
As noted in the press release issued by the Richmond Vascular Center, the “rapid maturation” is important because it can potentially reduce or even eliminate the length of time patients require a central venous catheter for dialysis.
The study also demonstrated real-world outpatient use of the Ellipsys endoAVF system. It evaluated the application of best practices for early maturation that include performing balloon angioplasty during fistula creation to improve blood flow and completing maturation after 4 weeks. In addition to shortening the dialysis timeline, this protocol decreased the overall number of secondary maturation procedures required to prepare the fistula for dialysis and reduced the rate of thrombosis, a common complication with fistula creation.
“Catheters are a less-than-optimal choice for dialysis access and the goal is to always get them out as soon as possible to avoid serious complications,” commented Dr. Hull in the press release. “With Ellipsys, we have the unique ability to create fistulas in the office during the patient’s initial visit, thus avoiding surgery at the hospital and reducing physician visits. This enables us to streamline the dialysis timeline and reduce patients’ total catheter contact by a significant amount—sometimes by as much as 4 months. This will have a tremendous impact on quality of life for patients.”