FDA Approves Two New AV Fistula Devices

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The U.S. Food and Drug Administration (FDA) has granted marketing approval for two catheter devices used in dialysis. Both the everlinQ endoAVF System, which uses two catheters, and the Ellipsys Vascular Access System with a single catheter are designed to create arteriovenous (AV) fistulas, using an energy source to forge the connection between blood vessels in a patient’s arm. Traditionally a central venous catheter for dialysis patients is created through a surgical process. An AV graft uses a tube or cadaveric blood vessel to create a bridge between artery and vein.

The FDA reviewed data for the everlinQ endoAVF System