Artio Medical announced today it has completed enrollment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the cardiovascular department at Sanatorio Italiano Hospital in Asunción, Paraguay.
“I am very pleased with my initial experience using the Amplifi system,” Ebner said. “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 arteriovenous (AV) fistulas in all patients after treatment, including patients who were poor candidates for AV fistula before treatment.”
The Amplifi system is designed to stimulate arm vein enlargement in hemodialysis patients using rapid, non-pulsatile venous blood flow. After seven days of treatment, the device is removed during surgery to create an AV fistula. The Amplifi vein dilation system aims to make more hemodialysis patients eligible to receive an AV fistula, increase fistula maturation success, reduce maturation time, and prolong the usable life of these fistulas. Amplifi is the first and only medical device intended to dilate and prepare veins prior to AV fistula surgery, according to an Artio Medical press release.
“I am grateful for Dr. Ebner and the entire team at Sanatorio Italiano who contributed to the success of this first-in-human study,” said F. Nicholas Franano, president and CEO of Artio Medical. “The company looks forward to sharing data on these first five patients in the coming months and building upon this promising early clinical experience. We remain focused on delivering a much-needed solution to the millions of patients worldwide who need hemodialysis.”