FDA Permits Marketing of Devices to Create Arteriovenous Fistula

Share this content:
FDA Permits Marketing of Devices to Create Arteriovenous Fistula
FDA Permits Marketing of Devices to Create Arteriovenous Fistula

TUESDAY, July 3, 2018 (HealthDay News) -- The U.S. Food and Drug Administration has permitted marketing of two catheter-based devices designed to create an arteriovenous (AV) fistula in patients with chronic kidney disease in need of hemodialysis.

The devices are designed to create AV fistulas percutaneously; the AV fistulas are needed before patients can start hemodialysis. A catheter is inserted into a blood vessel in the arm and guided to the site of the planned fistula. The Ellipsys Vascular Access System and everlinQ endoAVF System use one and two catheters, respectively.

For the Ellipsys Vascular Access System, the FDA reviewed data from a study involving 103 patients. Three months after the procedure, 89.3 percent of the patients met the criteria for a usable AV fistula. To maintain the fistula, almost all patients (96.1 percent) required an additional procedure in the first 12 months. For the everlinQ endoAVF System, the FDA reviewed data from 60 patients in a multicenter study, as well as data from other studies. In the main study, 86.7 percent of patients met the criteria for a usable AV fistula within three months after the procedure. Overall, 96.7 percent of patients required an additional procedure at the time that the fistula was created.

"With today's action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis," Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said in a statement.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Both Abstinence and High Alcohol Use Linked to Dementia

Both Abstinence and High Alcohol Use Linked to ...

Increased dementia risk for those with abstinence or with drinking >14 units alcohol/week in midlife

Intervention Cuts Risk for HIV in Young Transgender Women

Intervention Cuts Risk for HIV in Young Transgender ...

Intervention group had greater reduction in condomless sex acts versus standard of care group

Trauma Surgery Association IDs Steps to Curb Firearm Violence

Trauma Surgery Association IDs Steps to Curb Firearm ...

14 recommendations include actions to be taken by federal government, professional bodies

is free, fast, and customized just for you!




Already a member?

Sign In Now »