FDA permits marketing of devices to create arteriovenous fistula

July 4, 2018

(HealthDay)—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 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 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.

Explore further: New magnet technology creates easy blood access for hemodialysis patients

More information: More Information

Related Stories

New magnet technology creates easy blood access for hemodialysis patients

June 14, 2017
A new, minimally invasive system which uses radiofrequency energy instead of open surgery to create access for patients needing hemodialysis is reliable, with minimal complications, according to data published in the American ...

New research shows promise for improving vascular access for hemodialysis patients

August 16, 2017
Approximately 500,000 Americans with end-stage renal disease rely on hemodialysis to survive. Hemodialysis requires repeated access to the blood. Failure to maintain adequate access to the vasculature is a major cause of ...

Catheters linked with high risk of infections, heart problems, and death in dialysis patients

February 21, 2013
Dialysis patients using catheters to access the blood have the highest risks for death, infections, and cardiovascular events compared with patients using other types of vascular access, according to an analysis appearing ...

Racial disparities seen in initial access to blood flow for hemodialysis

April 29, 2015
Black and Hispanic patients will less frequently than white patients start hemodialysis with an arteriovenous fistula (connecting an artery to a vein for vascular access), a procedure for initial blood flow access known to ...

FDA permits marketing of new device for treating GI bleeding

May 9, 2018
(HealthDay)—The U.S. Food and Drug Administration has approved the new Hemospray device to help control bleeding of the gastrointestinal (GI) tract.

Recommended for you

'Good cholesterol' may not always be good

July 19, 2018
Postmenopausal factors may have an impact on the heart-protective qualities of high-density lipoproteins (HDL) - also known as 'good cholesterol' - according to a study led by researchers in the University of Pittsburgh Graduate ...

Using adrenaline in cardiac arrests results in less than 1 percent more people leaving hospital alive

July 18, 2018
A clinical trial of the use of adrenaline in cardiac arrests has found that its use results in less than 1% more people leaving hospital alive—but almost doubles the risk of severe brain damage for survivors of cardiac ...

Omega 3 supplements have little or no heart or vascular health benefit: review

July 17, 2018
New evidence published today shows there is little or no effect of omega 3 supplements on our risk of experiencing heart disease, stroke or death.

Researchers discover new genes associated with heart function

July 17, 2018
A new study from an international research team, led by Dr. Yalda Jamshidi at St George's, University of London, has identified new genes associated with heart function and development.

Southern diet could be deadly for people with heart disease

July 12, 2018
People with a history of heart disease who eat a traditional Southern diet are more likely to die than those who follow a Mediterranean dietary pattern, according to new research.

Late-life high blood pressure may harm the brain, study says

July 11, 2018
Decades ago, hundreds of nuns and priests made an extraordinary decision: They agreed to donate their brains upon death to science, hoping to help solve mysteries about Alzheimer's and other diseases. Now, a study that used ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.