Artio Medical announced that full results from its first-in-human clinical study of the Amplifi vein dilation system were presented at the 2021 VEITHSymposium (Nov. 16–20, Orlando) by Surendra Shenoy, MD, associate professor of surgery in the Washington University School of Medicine at Barnes-Jewish Hospital, St Louis.
“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 hemodialysis eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation rates.
“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,” Shenoy added.
“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.”