Artio Medical recently announced that it has successfully completed the first human use of its Amplifi vein dilation system. The first clinical procedure was performed by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion, Paraguay.
“Vascular access is a constant challenge for end stage renal disease patients who depend on haemodialysis treatment. 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,” commented Ebner.
“Many also frequently experience access site complications, often resulting in hospitalisation 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.”
Artio Medical’s Amplifi vein dilation system is designed to stimulate arm vein enlargement in haemodialysis patients using rapid, non-pulsatile blood flow. The innovative 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 seven to 10 days and removed completely during AVF creation.
“I believe this device has the potential to change the standard of care for haemodialysis patients, allowing more patients to be eligible for AVF surgery and reducing the risk of AVF failure and abandonment,” continued Ebner. “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 first-of-its-kind vein dilation technology through the acquisition of Flow Forward Medical in June 2020. The Amplifi vein dilation system aims to address common issues related to vascular access site creation and maintenance for the 2.3 million patients worldwide with end-stage renal disease who require haemodialysis. Artio expects to complete the first-in-human clinical study in the first half of 2021.