Fresenius Medical Care’s Hemodialysis System Earns Breakthrough Approval
The FDA granted breakthrough a device designation for Fresenius Medical Care’s blood-clot preventing dialysis device.
The device reduces the need for patients to use blood thinners, allowing them to avoid potential side effects caused by the medicines. It uses the additive Endexo, a polymer made of surface modifying macromolecules that can potentially reduce the risk of blood clots.
“We are hopeful this new system will help eliminate the reliance on heparin during dialysis,” said Robert Kossmann, Fresenius’ chief medical officer.