Vein Dilation System Improves Hemodialysis Vascular Access

A novel dilation system stimulates arm vein enlargement in hemodialysis patients in order to rapidly create an arteriovenous fistula (AVF).

The Artio Medical (Prairie Village, KS, USA; ) Amplifi Vein Dilation System is based on a wearable, external blood pump designed to stimulate arm vein enlargement using rapid, non-pulsatile blood flow that is delivered via an inflow catheter placed in the central venous system, and an outflow catheter inserted into the peripheral arm vein intended for enlargement. The entire process is regulated by adjusting pump speed, using a controller equipped with a rechargeable battery. After seven days of treatment, the device is removed during surgery to create an AVF.

“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,” said Adrian Ebner, MD, head of the cardiovascular department at Sanatorio Italiano Hospital (Asuncion, Paraguay), who performed the first five cases. “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.”

“Artio Medical is committed to developing novel devices that have the potential to provide better patient outcomes,” said F. Nicholas Franano, MD, President and CEO of Artio Medical. “Many thanks to Dr. Ebner and the entire clinical team at Sanatorio Italiano for helping Artio reach this important milestone. We look forward to sharing the results of our first clinical experience with the Amplifi system.”

An AVF is the most recommended access for kidney disease patients undergoing dialysis, created by connecting a patient's vein and artery to form a long-lasting site through which blood can be removed and returned. After the creation of an AVF, blood flow increases immediately, reaching 700–1,000 mL/min within one month. Both the artery and the vein dilate and elongate in response to the greater blood flow and shear stress, but the vein dilates more. When the vein is large enough to allow cannulation, the fistula is defined as mature.

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