Vascular access devices for hemodialysisSeptember 14, 2018
The U.S. Food and Drug Administration permitted marketing of two catheter-based devices, the Ellipsys Vascular Access System and the everlinQ endoAVF System, to make connections to veins and arteries for hemodialysis patients.
The catheters are designed to create what’s called an arteriovenous (AV) fistula in patients with chronic kidney disease who need hemodialysis.
The devices are designed to create AV fistulas percutaneously. A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, while the everlinQ endoAVF System uses two.
Before patients can start, dialysis patients need to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the mature vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically take several months to heal, and for the vein to mature before being usable for hemodialysis.
The Ellipsys Vascular Access System and everlinQ endoAVF System were reviewed through the De Novo premarket review pathway, a regulatory pathway for some low-to-moderate-risk devices of a new type.