FDA Approves Noninvasive Devices for Arteriovenous Fistula Creation
The devices use 1 or 2 catheters placed within the blood vessels to form AVFs in the arms of patients on hemodialysis.
The FDA has granted marketing approval for 2 catheter-based systems for the percutaneous creation of arteriovenous fistula (AVF): Ellipsys Vascular Access System (Avenu Medical) and the everlinQ endoAVF (TVA Medical).
“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today's action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, stated in a news release from the agency.
In both systems, a catheter is threaded into a blood vessel in the arm to the site of the intended AVF. Energy emitted from the devices creates a connection between an upper forearm artery and an adjacent vein. Use is only allowed in vessels that are more than 2 mm in diameter and close to each another. The Ellipsys Vascular Access System uses 1 catheter and the everlinQ endoAVF System uses 2.
The Ellipsys Vascular Access System was approved based on a non-randomized, multi-center study of 103 patients. The success rate was 89% for a usable AVF within 3 months. Virtually all patients required a second procedure, such as balloon angioplasty, in the first year to keep the AVF open.
The everlinQ endoAVF System approval involved a non-randomized, multi-center study of 60 patients and supporting data from 3 other studies. In the main study, the success rate was 87%. Almost all patients required an additional procedure at the time the AVF was created. In addition, more than a quarter of patients required another procedure in the first year to maintain the AVF.
Complications include occlusion, stenosis, bruising, and the need for additional procedures.
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients. FDA; June 22, 2018 [news release]