Pivotal Trial Evaluates Avenu's Ellipsys Vascular Access System
January 3, 2018—Findings from the United States pivotal multicenter trial of the Ellipsys vascular access system (Avenu Medical, Inc.) were published by Jeffrey E. Hull, MD, et al online ahead of print in Journal of Vascular and Interventional Radiology (JVIR). The study evaluated the safety and efficacy of arteriovenous fistulas (AVFs) created with Ellipsys, which is a thermal resistance anastomosis device.
As summarized in JVIR, the prospective, single-arm trial enrolled 107 patients at five sites. Patients underwent ultrasound-guided anastomosis creation between the proximal radial artery and perforating vein with the Ellipsys system followed by separate maturation procedures. Primary endpoints were brachial artery flow volume ≥ 500 mL/min and target vein diameter ≥ 4 mm in > 49% of patients and absence of device-related complications at 90 days.
AVFs with fused anastomoses were created in 95% (102/107) of patients. Maturation procedures included anastomotic balloon dilation in 72% (77/107), brachial vein embolization in 32% (34/107), cubital vein ligation in 31% (33/107), and surgical transposition in 26% (28/107) of patients.
Primary flow and diameter endpoints were achieved in 86% (92/107) of patients, exceeding performance goal of 49% (P < .0001). No major adverse events were attributed to the device.
The investigators reported that cumulative patency was 91.6%, 89.3%, and 86.7% at 90, 180, and 360 days, respectively. Target dialysis veins were cephalic, basilic, and brachial veins in 74% (73/99), 24% (24/99), and 2% (2/99) of patients, respectively. Two-needle dialysis was achieved in 88% (71/81) of patients on hemodialysis at a mean 114.3 ± 66.2 days. Functional patency was 98.4%, 98.4%, and 92.3% at 90, 180, and 360 days, respectively.
Ellipsys met the primary safety and efficacy endpoint goals in this pivotal trial, concluded the investigators in JVIR.
In 2016, Avenu Medical announced European CE Mark approval for the commercial sale of the Ellipsys vascular access system for hemodialysis. In the United States, Ellipsys is an investigational device and is limited by federal law to investigational use and is not for sale.