FDA Allows Marketing Of First Catheter-Based System Used To Create Vascular Access For Hemodialysis Patients

The US Food and Drug Administration (FDA) granted marketing authorization of 2 catheter-based devices, Ellipsys Vascular Access System and the everlinQ endoAVF System, designed to create an arteriovenous fistula in patients with chronic kidney disease in need of hemodialysis.

The devices granted authorization are designed to create AV fistulas percutaneously, which deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses 1 catheter, while the everlinQ endoAVF System uses 2.

“Dialysis is a necessary and life-saving procedure for thousands of individuals,” Bram Zuckerman, MD, director, Division of Cardiovascular Devices, FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA reviewed data for the everlinQ endoAVF System from a non-randomized, multi-center study of 60 patients, as well as data from 3 other studies and clinical use of the device outside the US, in which the system was used in a procedure to create an AV fistula.

In the main study, 52 patients (86.7%) met the criteria for a usable AV fistula within 3 months after the procedure. Almost all of the patients (96.7%) required an additional procedure at the time of the fistula creation, while 28.3% required an additional procedure, like balloon angioplasty, in the first 12 months to maintain the fistula.

It’s recommended that the devices not be used for creation of anastomoses in vessels that are less than 2 millimeters in diameter or too far apart.

Complications for both devices include occlusion or stenosis of the fistula, bruising and need for additional procedures.

The devices were reviewed through the De Novo premarket review pathway.