FDA grants breakthrough device designation to dialysis system that prevents blood clots
Fresenius Medical Care has received breakthrough device designation from the FDA for its hemodialysis system, which was designed to prevent blood clotting without the use of blood thinner medication.
“We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients,” Robert Kossmann, MD, chief medical office for Fresenius, said in a press release. “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 the market as quickly as possible.”
According to the release, an antithrombogenic additive is being incorporated into the manufacturing process of dialyzers and bloodlines to reduce clot risk and increase hemocompatibility.
“Harnessing out innovational expertise, we continuously strive to make significant advances in our products and provide new solutions for people with chronic kidney disease worldwide,” Olaf Schermeier, PhD, CEO for global research and development at Fresenius, said. “Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients’ well-being.”
Research supportive of the system will be presented at the American Society of Nephrology’s Kidney Week in November, from which Healio/Nephrology will be providing live coverage.