VenoStent’s SAVE-FistulaS clinical trial is enrolling 200 participants
If your kidneys are failing, and your physician is referring you to undergo an arteriovenous fistula (AVF) creation surgery that connects an artery to a vein in your arm to allow for hemodialysis treatments, you may be eligible for this study.
AVFs often fail (50 – 60% of the time within the first year) due to the vein growing inwards. This results in a blockage of blood flow that is inadequate to support dialysis treatments through the AVF.
A primary reason why AVFs fail is because the vein is not built strong and elastic like an artery, and cannot withstand the 10x increase in pressure and flow that it experiences from the AVF creation surgery.
VenoStent’s SelfWrap has been bioengineered to address this problem with a wrap that goes around the vein-artery junction to provide mechanical support, essentially strengthening the vein so that it can adapt to its new high pressure, high flow environment.
SelfWrap is currently in the research and development phase and is not available for sale in any country. Investigational device. Limited by federal law to investigational use.