Artio Medical has announced that full results from its first-in-human clinical study of the Amplifi vein dilation system were presented at the 2021 VEITHSymposium (16–20 November, Orlando, USA and virtual) by Surendra Shenoy, associate professor of surgery in the Washington University School of Medicine at Barnes-Jewish Hospital (St Louis, USA).
“Data from the first five patients treated with the Amplifi system demonstrated more than a doubling of forearm and upper arm cephalic vein diameters following a mean treatment period of 8.6 days,” said Shenoy. “We were able to successfully create an arteriovenous fistula (AVF) using treated veins in all patients and observed rapid and robust AVF maturation. These data are very encouraging, and I believe this technology has the potential to offer a much-needed solution for increasing AVF suitability and reducing maturation failure.”
The Amplifi vein dilation system is designed to stimulate arm vein enlargement prior to AVF creation to make more patients requiring vascular access for haemodialysis eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation rates, an Artio press release states.
“When physicians create AVFs today, we know there are often vein segments with pre-existing problems, but we do not currently have adequate tools to identify these segments—which contributes to the high rate of AVF maturation failure,” Shenoy added. “The Amplifi system could allow physicians to better identify these segments and either treat them at the time of AVF creation or exclude them from the AVF circuit.
“In this study, three of the five patients had pre-existing problems in the cephalic vein, which were made more apparent by Amplifi system treatment. In one patient, an AVF was made more proximally and, in another, angioplasty was performed, and both patients went on to have successful AVF maturation and use.”
Erdie De Peralta, vice president of clinical and regulatory affairs at Artio, said: “We are pleased to have the data from the Amplifi system FIH [first-in-human] presented at the VEITH conference and look forward to building upon this initial clinical experience with our US IDE [investigational device exemption] trial, which is projected to begin enrolment in 2023.”
