At the Society for Vascular Surgery’s 2019 Vascular Annual Meeting in Maryland, vascular surgeon Alexandros Mallios, M.D., of Institut Mutualiste Montsouris of Paris, France presented on his two-year experience performing non-surgical creation of AV fistulae utilizing the FDA cleared Ellipsys Vascular Access System from Avenu Medical Inc. Mallios shared the data he has gathered from successfully creating AV fistulae utilizing the Ellipsys technology in 216 of his patients.
Ellipsys, a minimally invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis, provides physicians and patients access to a unique non-surgical option for AV fistula creation, a necessary procedure for patients who require dialysis. In his presentation, Mallios outlined the benefits of using the Ellipsys System to create a percutaneous AV fistula.
In his presentation, titled “Percutaneous Arteriovenous Fistula Creation Using a Single Catheter Device and Ultrasound Guidance,” Mallios described how functional dialysis access was established within an average of four weeks, allowing for the life-saving blood cleansing to begin. He also explained that no major complications were encountered related to the procedures.
“It appears that thanks to a moderate flow and low pressure that we see in these percutaneous fistulae, patients can now have peace of mind in the long-term, avoiding repeated operations and other common chronic problems that patients get when they have a regular, surgical fistula,” said Mallios.
“We found percutaneous AV fistula creation using the proximal radial artery for inflow offers prompt maturation times, excellent technical success and patency rates with a very high safety profile,” added Mallios of his experience to date with the technique and technology. “Our patients are happy and proud of their percutaneous fistulae, having their arms preserved with a normal appearance avoiding the formation of aneurysms while providing an excellent access for hemodialysis. Based on the data we have gathered after treating 216 patients, we believe this revolutionary new technique and technology will have a tremendous positive effect on the worldwide ESRD population that needs this procedure.”
“Dr. Mallios’ compelling data adds to the rapidly mounting evidence that Ellipsys has clearly emerged as the gold standard for endoAVF procedures,” said Mark Ritchart, president of Avenu Medical. “Because there is currently a shortage of dedicated vascular access surgeons who can create AV fistulae, our Ellipsys System can increase the number of clinicians performing vascular access procedures, which can in turn improve patient care by dramatically reducing the waiting time from request for fistula to usable access for dialysis. This, in turn, reduces the morbidity associated with temporary catheter access. In short, it represents significant quality of life improvement opportunity for this patient community.”
The Ellipsys System transforms an open surgery connecting an artery to a vein into a minimally invasive procedure using a needle and a catheter. Using a percutaneous approach, the Ellipsys procedure replaces a long skin incision with a needle puncture, surgical dissection with ultrasound imaging, and sutures with tissue fusion. The procedure can be performed in the physician’s office, hospitals and ambulatory surgery centers. After the procedure, the patient leaves with just a small bandage.
The Society for Vascular Surgery’s 2019 Vascular Annual Meeting is designed to provide attending clinicians opportunities to learn more about cutting-edge vascular research, attend innovative educational sessions, and get inspired to bring new ideas back to the office and operating room.