Fresenius Medical Care North America's Renal Therapies Group is preparing its first shipment of multiBic dialysate solutions for use in continuous renal replacement therapy (CRRT). These efforts will support hospitals faced with COVID-19 pandemic-related increases in acute kidney injury. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) this month to these solutions as well as the multiFiltrate PRO System for use in acute care settings during the COVID-19 pandemic.
There is increasing evidence that COVID-19 leads to multi-organ failure, including acute kidney injury (AKI), increasing demand for CRRT far above normal levels. As a result, the company has been working on multiple fronts to support a continuous supply of dialysis machines and solutions to hospitals across the country, including the NxStage System One S. The multiFiltrate PRO, which is CE-marked and currently widely available in Europe, will create a stronger supply of critical care machines in the U.S. able to provide CRRT for patients with AKI.
"We appreciate the FDA's quick action in order to get these needed supplies and equipment into the U.S. for emergency use to provide CRRT to treat more patients with acute kidney injury and to help save more lives," said Bill Valle, CEO of Fresenius Medical Care North America (FMCNA). "This is just one part of a larger effort to support continuous supply of critical care machines and dialysis solution for our nation's hospitals."
Earlier the company announced the formation of its National Intensive Renal Care Reserve which has been working to deploy available NxStage System One S machines across the country to those hospitals most in need, as well as deploying similar portable units typically used for home dialysis or in skilled nursing homes. The company also announced that it had increased production of its tubing and filter sets, along with premixed dialysate fluid. To date, this Reserve has helped multiple hospitals along the East Coast and Upper Midwest support patient care during this unprecedented crisis.
"Since we first became aware of the increasing demand for dialysis due to COVID-19, we have been working diligently to support hospitals with the needed critical care equipment and supplies," said Joe Turk, President of Home and Critical Care Therapies at FMCNA. "While the early experiences in other geographies appears to be less challenging than in the New York metropolitan area, the option to support our nation's hospitals with these systems brought in under EUA will allow us to even better serve patients during this pandemic."