Fresenius Medical Care North America (FMCNA), a US-based kidney care products and services provider, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its new haemodialysis system, which is under development.
FMCNA said that the new haemodialysis system has been designed to prevent blood clotting in patients without the use of blood thinner medication.
Fresenius Medical Care global research and development chief executive officer Olaf Schermeier said: “Harnessing our innovational expertise, we continuously strive to make significant advances in our products and provide new solutions for people with chronic kidney disease worldwide.
“Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients’ well-being.”
The new dialysis system uses Endexo and Citrasate
According to the company, most dialysis patients are prescribed blood thinners such as heparin to reduce the risk of blood clotting while using bloodlines and dialyzers.
Endexo, a polymer made of surface modifying molecules to inhibit the adsorption of protein and platelets for potentially reducing clot risk and increasing haemocompatibility, and Citrasate, a dialysate, are used as part of the new system.
Endexo and Citrasate used in the new dialysis system are set to reduce the need for these blood thinners, which can have dangerous side-effects.
Fresenius Medical Care has secured an exclusive international licence from Interface Biologics to use the Endexo technology in haemodialysis devices, including dialyzers and bloodlines.
FMCNA said that the current US FDA Breakthrough Device Designation marks the second regulatory designation it has obtained in 2019. The company secured the designation to its computer-assisted ultrafiltration (UF) control software to improve fluid management during haemodialysis and personalise treatments.
The company intends to present the research supporting the development of the new dialysis system at the American Society of Nephrology’s Kidney Week in November 2019.
FMCNA renal therapies president Mark Costanzo said: “This new dialysis system builds on our commitment to innovate in ways that continuously improve patient safety and health outcomes. We are proud to be leading the way in designing the future of life-sustaining dialysis treatments.”
FMCNA chief medical officer Robert Kossmann said: “We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients.
“The work to achieve this breakthrough has been years in the making and we are excited that the FDA has recognized the importance of bringing this technology to market as quickly as possible.”
