Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced that preliminary clinical results from its first-in-human study of the Amplifi™ Vein Dilation System were presented at the 2021 Vascular Interventional Advances (VIVA) conference. Data were presented during a Late-Breaking Clinical Trial session by Surendra Shenoy, MD-PhD, an Associate Professor of Surgery at the Washington University School of Medicine at Barnes-Jewish Hospital in St. Louis, Missouri.
A reliable, long-lasting vascular access site is critical for end-stage renal disease patients who require lifesaving hemodialysis treatment. Although an arteriovenous fistula (AVF) is the preferred form of vascular access, many hemodialysis patients are not suitable for an AVF, often due to small vein diameters. For those patients who are suitable, AVF maturation failure rates are high and prior studies have shown a correlation between small vein diameter and failure.1
Data presented from the first five patients treated in a prospective, non-randomized, single-arm first-in-human clinical study with Artio Medical’s Amplifi Vein Dilation System demonstrated more than a doubling of forearm and upper arm mean cephalic vein diameters with a mean treatment period of 8.6 days. AVFs were successfully created using treated veins in all patients. Maturation data is available for the first three patients showing that both the forearm and upper arm AVFs matured quickly with mean outflow vein diameter of 7 mm and a mean blood flow rate more than 1,000 mL/min after a 6-week maturation period. No device or procedural adverse events were observed.
The Amplifi System is designed for percutaneous placement and up to 14 days of use to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile, venous blood flow. The device includes a wearable external blood pump, inflow and outflow catheters, and a controller all of which are removed completely during AVF creation. The company is planning for a potential US clinical trial in 2022.
“I was excited to have the privilege to present these results from Artio’s first-in-human study with the Amplifi System at the 2021 VIVA Conference Late-Breaking Clinical Trial session,” commented Surendra Shenoy, MD-PhD. “Not long after AVFs were first pioneered for hemodialysis in 1966 by doctors Cimino, Brescia, and Appel, concerns were raised about patients who were not suitable for AVF surgery and the high rate of AVF maturation failure. Despite these challenges, AVF remains the preferred option for most patients today. The Amplifi System is the first device I have seen that has real potential to address both of these challenges in a major way, to make good on the promise of providing reliable, long-lasting vascular access sites for this unique and vulnerable patient population.”
First human use in January 2021.