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December 5, 2019

Two-Year Data Reported for Avenu’s Ellipsys Vascular Access System

December 5, 2019—Access Solutions, a provider of patient advocacy consulting services in the dialysis industry, announced the publication of a study reporting high levels of patient satisfaction with a minimally invasive endovascular approach to creating vascular access for patients who require hemodialysis. In addition, the study showed that approximately all of the dialysis access sites, or fistulas, were still functional after 2 years—a significant improvement over surgically created fistulas.

“Two-Year Cumulative Patency of Endovascular Arteriovenous Fistula” was published online in Journal of Vascular Access by Gerald A, Beathard, MD; Terry Litchfield, MPA; and William C. Jennings, MD. The study is the first published 2-year data for any endovascular fistula procedure, stated Access Solutions.

Dr. Beathard, is an interventional nephrologist at the University of Texas Medical Branch in Galveston, Texas. Dr. Jennings is a vascular surgery at the University of Oklahoma in Tulsa, Oklahoma. Terry Litchfield, who is President of Access Solutions, has been a patient advocate in the renal community for more than 30 years.

According to the announcement, the multicenter study was composed of 105 patients in the United States who had their fistulas created with the Ellipsys vascular access system (Avenu Medical) and who had a minimum of 2 years of follow-up. Patients’ responses in the study emphasized the avoidance of surgery, a perceived lack of pain, and improved body image when compared with patients who underwent surgery.

Dr. Beathard commented in Access Solutions’ press release, “The dramatic difference in durability between the endovascular fistulas and the surgically created ones is striking. The ability to quickly and easily create a fistula that will last a long time, without surgical trauma or the need for additional procedures, could represent a significant advance in dialysis patient care.”

Also in the announcement, Ms. Litchfield stated, “We knew fistulas created with Ellipsys functioned well in the beginning, but patients wanted to know how long their access sites would last. Our goal was to see how many still worked after 2 years while capturing patients’ opinions on this innovative procedure. The results were overwhelmingly positive from both a patient and clinical perspective.”

The survey responses indicated that 93% of patients rated their overall satisfaction with the procedure as “excellent” or “very good.” The investigators also reported that approximately 92% of the fistulas continued to function 2 years after the Ellipsys procedure. In contrast, fewer than two-thirds of surgically created fistulas were still functional after 2 years.

Approved by the FDA in 2018 for patients with end-stage renal disease, Ellipsys transforms a complex surgery into a minimally invasive procedure that can be performed in a hospital outpatient setting or ambulatory surgical center. A faster recovery allows patients to start hemodialysis sooner. The lack of scars or disfigurement typically associated with surgical fistulas means a more normal cosmetic appearance—something the study revealed is very important to patients, noted Ms. Litchfield.

She commented further, “In keeping with the national Advancing American Kidney Health Initiative, this new technology gives kidney patients another choice for vascular access that has the potential to improve their quality of life. It’s exciting to see the push for innovation in dialysis access and even more exciting that patients’ voices are being included in the process.”

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