June 21, 2018
Percutaneous AV Fistula Creation Systems Gain FDA Marketing Authorization
June 22, 2018—The US Food and Drug Administration has announced the marketing authorization of two systems designed to percutaneously create arteriovenous (AV) fistulas in hemodialysis patients. The Ellipsys Vascular Access System (Avenu Medical) and the everlinQ endoAVF System (TVA Medical) are poised to enter the US market after having been reviewed via the FDA's De Novo premarket review pathway. This new regulatory classification will allow for future devices to be reviewed through the agency's 510(k) clearance process.
"With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” said Bram Zuckerman, Director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health in the agency's announcement.
“The everlinQ endoAVF System is a significant advance in the management of chronic kidney disease,” commented Paul Kreienberg, MD, in a TVA Medical announcement of the approval. Dr. Kreienberg is a vascular surgeon with The Vascular Group, Albany Medical College, Albany Medical Center Hospital, in Albany, New York. “Hundreds of thousands of Americans require vascular access for lifesaving dialysis, but until now this access has required open surgery that is accompanied by high failure rates and low patient satisfaction. The everlinQ endoAVF System is transforming vascular access using a minimally invasive approach, and I anticipate a high level of interest from both patients and physicians for this compelling endovascular solution.”
"Today's FDA approval of devices for percutaneous fistula creation will be of great benefit to end-stage renal disease population," said Jeffrey E. Hull, MD, founder and consultant to Avenu Medical and Director of the Richmond Vascular Center in North Chesterfield, Virginia, in comments to Endovascular Today. "We are anticipating a major paradigm shift in the vascular access space. Congratulations to our team members who have worked long and hard to reach this milestone."
Contraindications for the devices include creation of anastomoses in vessels less than 2 mm in diameter or those too far apart. The FDA cited potential complications such as fistula occlusion or stenosis.
For an in-depth look at percutaneous AV fistula creation and the platforms receiving marketing authorization, please see the links below:
Drs. Hull and Deeraj Rajan describe the features and mechanisms of action of each platform and their applications.
Trialists detail their clinical experiences and address questions during a dedicated session at a previous Society of Interventional Radiology meeting.
An expert panel shares insights into how percutaneous AV fistula creation might fit into practices once approved.