SAN JUAN CAPISTRANO, Calif., March 3, 2020 /PRNewswire/ -- The Ellipsys® Vascular Access System enables patients with kidney failure to start dialysis treatment sooner with fewer procedures, complications and interventions compared to surgery, according to several leading physicians who spoke at the recent meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN).
Interventional radiologist Jeffrey Hull, M.D., was awarded first place for his oral presentation on the Ellipsys US Registry.
For end-stage renal disease (ESRD) patients who require hemodialysis, the Ellipsys System from Avenu Medical offers a minimally invasive way to create a type of vascular access known as an arteriovenous fistula (AVF). Until recently, the only way to create an AVF was a complex surgical procedure that subjects patients to discomfort, longer recovery times and delayed dialysis. In contrast, Ellipsys uses just a small needle puncture and catheter to create an endovascular AVF (endoAVF).
According to Dr. Hull, the unique ability to perform maturation procedures at the time of endoAVF creation dramatically reduces the amount of time between fistula creation and dialysis—from six months with surgical AVFs to as little as four to six weeks with Ellipsys.
Accelerating this process is important because it can potentially reduce the length of time patients require a catheter for dialysis. Compared to fistulas, central catheters are associated with significantly higher rates of complications, like infection and even death. Yet despite these risks, 80 percent of patients in the U.S. still start their dialysis with a catheter.
"With such serious complications, catheters are a less than optimal choice for dialysis access and the goal is to always get them out as soon as possible," said Dr. Hull. "Ellipsys enables us to streamline the dialysis timeline and reduce patients' total catheter contact by a significant amount—sometimes by as much as four months. This will have a tremendous impact on quality of life for patients."
Randy Cooper, M.D., an interventional nephrologist at SKI Vascular Center in Tempe, Ariz., presented his initial four-year data at ASDIN and discussed methods for maturing Ellipsys fistulas to get them ready for dialysis. His experience indicates that fistulas created with Ellipsys last longer, while requiring fewer maturation procedures and less intervention to maintain function over time.
"Based on both published research and my own data, it appears that at two years and beyond, the Ellipsys endoAVF outperforms surgically created fistulas in almost every respect—they mature faster, last longer and it's much less invasive for the patient," said Dr. Cooper. "With presentations like this, we are using our experience as a roadmap to help other physicians bring the benefits of this less invasive approach to their patients."
SKI Vascular Center was the first ambulatory surgical center in the United States to offer the Ellipsys System following its FDA approval in 2018.
Also at ASDIN, Dr. Hull, Dr. Cooper and Dr. Rajeev Narayan trained more than 70 physicians on the Ellipsys System at a hands-on endoAVF workshop. Rashid Sharaf, M.D., of Azura STAR Vascular Care in San Antonio, Texas, reported positive results using Ellipsys for more than 150 procedures.
Recently published two-year data reported that 92 percent of Ellipsys fistulas continued to function well after two years. The study also demonstrated high levels of patient satisfaction with the procedure. Dr. Hull, Dr. Cooper and Dr. Narayan are authors on the 2015 study that demonstrated the safety and efficacy of the Ellipsys system.
"We're thrilled about the amount of discussion surrounding the Ellipsys System within the nephrology community," said Mark Ritchart, President and CEO of Avenu Medical. "In addition to offering the first glimpse at some very promising four-year data, these presentations add to the growing body of evidence that our technology can reliably create durable fistulas with minimal intervention while reducing reliance on riskier vascular access options."
Ellipsys is the first innovation in AVF creation in over 50 years. It transforms a complex surgery into a minimally invasive procedure that can be performed in a hospital outpatient setting or ambulatory surgery center. Over 1,500 patients worldwide have had the Ellipsys procedure since 2015.
The ASDIN 16th Annual Scientific Meeting was held Feb. 21-23 in Las Vegas.
About Avenu Medical
Avenu Medical, Inc. was founded in 2010 to pursue unmet clinical needs in the ESRD and vascular access markets. The company's Ellipsys Vascular Access System is an innovative, ultrasound-guided, single catheter endoAVF system used to percutaneously create an arteriovenous (AV) fistula for hemodialysis access. Learn more at http://www.avenumedical.com.
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SOURCE Avenu Medical
