B. Braun Medical said today it won FDA 510(k) clearance for its xevonta dialyzer and that it is launching the next-generation filter in the U.S.
The new dialyzer features a filtration membrane designed to filter out smaller toxin molecules in patients’ blood, like urea and creatinine, while maintaining larger blood componenets, such as albumin and beta-2 microglobulin molecules.
“Our new dialyzer’s advanced membrane technology was designed to improve clearance performance by removing more toxins from a patient’s blood,” renal therapies division veep Samuel Amory said in a press release.
The Bethlehem, Penn.-based company said it expects to offer the xevonta filter in September, with a range of sizes for different patient accommodation requirements.