FIH Use of Artio Medical’s Amplifi Vein Dilation System Completed

January 27, 2021—Artio Medical, Inc. announced that it has successfully completed the first-in-human use of its Amplifi vein dilation system, which prepares a vessel for arteriovenous fistula (AVF) creation. The first clinical procedure was performed by Adrian Ebner, MD, Head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay.

According to the company, the Amplifi system stimulates arm vein enlargement in patients undergoing hemodialysis using rapid, nonpulsatile blood flow. The system is designed for percutaneous placement and includes a wearable external blood pump, inflow and outflow catheters, and a controller. The Amplifi system is used for 7 to 10 days and removed completely during AVF creation.

“Vascular access is a constant challenge for end-stage renal disease patients who depend on hemodialysis treatment,” commented Dr. Ebner in the company’s announcement. “Most patients are plagued with interrupted or delayed care due to repeated access site failures and require additional procedures and surgeries to maintain vascular access. Many also frequently experience access site complications, often resulting in hospitalization and the need for additional care. I am pleased to be a part of the first human use for the Amplifi system. This is the first technology that seeks to address these challenges by proactively preparing patient’s veins for AVF creation.”

Dr. Ebner continued, “I believe this device has the potential to change the standard of care for hemodialysis patients, allowing more patients to be eligible for AVF surgery and reducing the risk of AVF failure and abandonment. The degree of vein dilation we observed during the treatment period for the first patient was remarkable, and the AVF made with the treated vein matured very rapidly.”

Artio Medical acquired the vein dilation technology through the acquisition of Flow Forward Medical, Inc. in June 2020. The first-in-human clinical study is expected to be completed in the first half of 2021, advised the company.