B. Braun Medical said it will begin making its xevonta kidney dialyzer available in the U.S. this month, following the recent 501(k) clearance by the FDA.
Often referred to as an “artificial kidney,” the dialyzer is a dialysis filter that removes wastes and excess fluid from the blood when a patient's kidneys can no longer perform the task, the company said. The enhanced xevonta system can filter out smaller toxin molecules in a patient's blood, like urea and creatinine, while keeping most of the larger blood components, like albumin and beta-2 microglobulin molecules, that are vital to a patient's health.
The device will be available in a range of sizes to meet various patient needs.
"Our new dialyzer's advanced membrane technology was designed to improve clearance performance by removing more toxins from a patient's blood," Samuel Amory, vice president of the company’s renal therapies division, said in a statement.
B. Braun manufactures and distributes hemodialysis equipment and related disposables, including the Diacap Polysulfone dialyzers and Medisystems' Streamline Bloodlines.
Back in May, the company was slapped by the FDA with a Class I recall--the agency’s most serious--of more than 1,000 of its Dialog+ Hemodialysis Systems used to treat chronic kidney disease patients. The devices had the potential of allowing air to enter the dialysis solution, which could lead to improper blood filtration as well as other consequences including death.