Artio Medical’s Amplifi Vein Dilation System Evaluated in First-in-Human Trial

July 29, 2021—Artio Medical, Inc. announced it has completed enrollment in its first-in-human study evaluating the company’s Amplifi vein dilation system, which is intended to dilate and prepare veins before arteriovenous fistula (AVF) surgery.

Five patients were treated by Adrian Ebner, MD, the Head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay.

According to the company, the Amplifi system is a wearable, external blood pump system designed to stimulate arm vein enlargement in hemodialysis patients using rapid, nonpulsatile venous blood flow. After 7 days of treatment, the device is removed during surgery to create an AVF.

The Amplifi system aims to make more hemodialysis patients eligible to receive an AVF, increase AVF maturation success, reduce maturation time, and prolong the usable life of AVFs, stated Artio Medical.

“I am very pleased with my initial experience using the Amplifi system,” commented Dr. Ebner in the company’s press release. “The device was simple to implant and well tolerated by all patients. We observed significant vein enlargement in each enrolled patient and were able to successfully create AVFs in all patients after treatment, including patients who were poor candidates for AVF before treatment.”