Artio Medical’s Amplifi Vein Dilation System FIH Study Full Results Set Stage for United States IDE Trial in 2023

November 30, 2021—Artio Medical, Inc. announced that full results from its first-in-human (FIH) clinical study of the Amplifi vein dilation system were presented by Surendra Shenoy, MD, at the 2021 VEITHsymposium held November 16-20 in Orlando, Florida.

According to the company, the Amplifi vein dilation system is designed to stimulate arm vein enlargement before arteriovenous fistula (AVF) creation to make more patients eligible for AVF surgery, reduce the time required for AVF maturation, and increase successful maturation rates.

Findings from the study were previously presented by Dr. Shenoy during a late-breaking clinical trials session at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

The prospective, nonrandomized, single-arm, open-label, FIH clinical study of five patients with end-stage renal disease was conducted at Sanatorio Italiano in Asunción, Paraguay, and commenced in Q4 2020. Completion of enrollment in the trial was announced in July 2021.

In the company’s press release after the VEITHsymposium, Erdie De Peralta, Vice President of Clinical and Regulatory Affairs at Artio Medical, stated, “We are pleased to have the data from the Amplifi system FIH presented at the VEITH conference and look forward to building upon this initial clinical experience with our United States investigational device exemption trial, which is projected to begin enrollment in 2023.”

Dr. Shenoy, who is Associate Professor of Surgery at the Washington University School of Medicine at Barnes-Jewish Hospital in St. Louis, Missouri, commented in Artio’s press release, “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. We were able to successfully create an 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.”

Dr. Shenoy continued, “When physicians create AVFs today, we know there are often vein segments with pre-existing problems, but we don’t currently have adequate tools to identify these segments, which contributes to the high rate of AVF maturation failure. 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 conclusion, Dr. Shenoy noted, “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.”