FDA grants Fresenius breakthrough designation for hemodialysis system

The FDA has given Fresenius Medical Care a breakthrough device designation for their new hemodialysis system designed to avert blood clots internally, without patients having to take blood thinning medications. The hemodialysis system has Endexo, an anti-thrombogenic polymer made of surface-modifying macromolecules that aim to block platelets and proteins from sticking to and coating solid surfaces, which has the potential to diminish the risks of blood clots while also increasing the biocompatibility of its dialysis systems. Endexo is added during the manufacturing of dialyzers and blood flow lines and is permanently incorporated into the devices’ surfaces as they are produced. It is developed by Interface Biologics, and Fresenius holds an exclusive worldwide license to apply Endexo to various hemodialysis components.
Robert Kossmann, chief medical officer for Fresenius Medical Care North America, said: “We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients.”