July 21, 2020
Avenu Medical’s Ellipsys Vascular Access System Evaluated for Percutaneous AVF Creation
July 21, 2020—Avenu Medical, Inc. announced that findings from a study of the company’s Ellipsys vascular access system were published by Alexandros Mallios, MD, et al online in Journal of Vascular Surgery.
According to the company, the study demonstrated the benefits of the Ellipsys system to easily and safely create durable vascular access for patients with end-stage renal disease who require hemodialysis. The investigators also offered a standardized process for using the minimally invasive technology that other physicians can follow to reproduce the results. According to Dr. Mallios, the process “will make it easier for more practitioners to adopt this patient-friendly approach to dialysis access.” Dr. Mallios is a vascular surgeon at Institut Mutualiste Montsouris in Paris, France.
Dr. Mallios commented in the company’s announcement, “Vascular access is quite literally the lifeline for dialysis patients. The advantages of the percutaneous Ellipsys fistula are that it is a very safe, simple, and reproducible way to create a fistula that will function for a long time with minimal interventions.”
In contrast to open surgical procedures, the Ellipsys system uses a small needle puncture and catheter to create a percutaneous arteriovenous fistula (pAVF) without an implant or suture, leaving the vessels and tissue around the AVF undisturbed. Ellipsys was cleared by the FDA in 2018 for patients with end-stage renal disease. In 2016, Avenu Medical received European CE Mark approval of the Ellipsys vascular access system for hemodialysis.
The study by Mallios et al included 232 patients who had an Ellipsys pAVF created between May 2017 and July 2019. There were no adverse events. At 1 year, 96% had fully functioning fistulas with strong blood flow, whereas published rates for surgically created fistulas average around 60% after 1 year, the company noted.
In addition, the study reported that the pAVF could be used for dialysis an average of 4 weeks after creation, with 6% of fistulas becoming functional in as little as 2 weeks. The company noted that this rapid maturation can have a significant impact on patient safety because it avoids the use of a central venous catheter if a patient needs to begin dialysis quickly.
One of the most important aspects of the study, Dr. Mallios stated, is that it offers a protocol for fistula creation, maturation, and maintenance, which should make it easier for other physicians to adopt the relatively new procedure. For example, the study shows the benefit of adding a new step to the procedure: performing balloon angioplasty immediately after a fistula is created. This step improves blood flow, speeds maturation, and could improve patency rates without increasing the need for additional maintenance procedures.
Avenu Medical noted that Dr. Mallios et al recently published a case report of Ellipsys in Journal of Vascular Surgery (2020;71;1395). Dr. Mallios also coauthored two recent papers published online in The Journal of Vascular Access discussing patient eligibility for Ellipsys (“Feasibility for arteriovenous fistula creation with Ellipsys®”) and the similarities between an Ellipsys pAVF and a surgical AVF (“Ultrasound Evaluation of Percutaneously Created Arteriovenous Fistulae Between Radial Artery and Perforating Vein at the Elbow”).
Additionally, in The Journal of Vascular Access, “Two-Year Cumulative Patency of Endovascular Arteriovenous Fistula” by Gerald A. Beathard, MD, et al showed a long-term functional patency rate of 92% at 2 years (2020;21;350-356). The study also found high levels of patient satisfaction with the procedure, stated the company.