FDA OKs Two Devices for Endovascular AV Fistula Creation

Megan Brooks

Disclosures

June 22, 2018

The US Food and Drug Administration (FDA) has cleared two minimally invasive, catheter-based devices to create arteriovenous (AV) fistulas percutaneously in patients with chronic kidney disease who need hemodialysis access.

One is the Ellipsys Vascular Access System, from Avenu Medical, and the other is the everlinQ endoAVF System, from TVA Medical Inc.

The everlinQ endoAVF System and the Ellipsys Vascular Access System

More than 600,000 Americans have kidney failure, and most require hemodialysis. Surgically created AV fistulas typically take several months to heal and for the vein to mature before they are able to be used for hemodialysis.

"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, said in a press release.

With the two new devices, a catheter is inserted into a blood vessel in the forearm and is guided to the site of the planned AV fistula. Energy is delivered to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, and the everlinQ endoAVF System uses two, the FDA explained.

For the Ellipsys system, the FDA reviewed data from a nonrandomized, multicenter study of 103 patients in which the system was used to create an AV fistula. Of these, 92 patients (89.3%) had a usable AV fistula within 3 months after the procedure, but most (96.1%) required an additional procedure, such as balloon angioplasty, in the first 12 months to maintain the fistula, the agency said.

For the everlinQ endoAVF System, the FDA reviewed data from a nonrandomized, multicenter study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the United States.

In the main study, 52 patients (86.7%) had a usable AV fistula within 3 months after the procedure. Nearly all patients (96.7%) needed an additional procedure at the time the fistula was created; 28.3% of patients needed another procedure in the first 12 months to maintain the fistula.

The FDA said neither device should be used to create anastomoses in vessels measuring less than 2 mm in diameter or that are too far apart (eg, in the wrist or in the hand). For both devices, complications include occlusion or stenosis of the fistula, bruising, and the need for additional procedures.

Both devices were approved through the FDA's de novo premarket review pathway, which is used for novel low- to moderate-risk devices of a new type.

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