June 25 (UPI) — The U.S. Food & Drug Administration has approved marketing two catheter-based devices to connect to veins and arteries in patients with chronic kidney disease who need hemodialysis.
The agency approved the Ellipsys Vascular Access System and the everlinQ endoAVF System for patients who need hemodialysis access, according to an FDA release Friday.
About 468,000 Americans — about two-thirds of those kidney failure — are on hemodialysis, according to the National Institutes of Health.
“Dialysis is a necessary and life-saving procedure for thousands of individuals,” Dr. Bram Zuckerman, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “There will be additional, less-invasive vascular access options for patients who will require hemodialysis.”
In hemodialysis, a machine filters waste, salt and fluid from blood when kidneys can’t handle this work.
But before patients can start dialysis, they need to have an arteriovenous fistula created.
In the past, an AV fistula is made by surgically joining an artery and a vein under the skin in the arm. Several months after the vein heals, two needles can used for each hemodialysis session.
The new system is designed to create AV fistulas through the skin. A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The Ellipsys Vascular Access System uses one catheter and the everlinQ endoAVF System has two.
The FDA reviewed data from a non-randomized, multi-center study of 103 patients for the Ellipsys system and 60 patients for the other one. In both trials, around 96 percent of all patients required an additional procedure, such as a balloon angioplasty in the first 12 months to maintain the fistula.
The FDA said both systems should not be used for creation of connections in vessels that are less than 2 millimeters in diameter or too far apart such as in the wrist or in the hand.