Fresenius Medical Care North America’s Renal Therapies Group announced it has received breakthrough device designation from the FDA for its computer-assisted ultrafiltration control software.
According to a company press release, the product is being designed to work with newer Fresenius Medical Care hemodialysis machines using the company’s CLiC device, which enables relative blood volume monitoring (RBV-M). The new software aims to create a dialysis machine with embedded intelligent diagnostics that will provide computer-assisted recommendations for achieving target levels of RBV.
"This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure," Mark Costanzo, president of Renal Therapies Group, the technologies and pharmaceuticals division of FMCNA, said in the release.
In several abstracts presented at the 2018 ASN Kidney Week in San Diego, FMCNA researchers demonstrated that managing fluid with RBV-M was associated with reduced hospitalizations for patients new to hemodialysis and further established the link between RBV, central-venous oxygen saturation and mortality. According to the release, an additional analysis by the Renal Research Institute, published in Nephrology Dialysis Transplantation in September 2018, demonstrated that attainment of certain hourly RBV ranges is associated with improved survival in patients with ESRD receiving hemodialysis.