Fresenius Medical Care AG & Co. KGaA's dialysis system that prevents blood clotting without the use of blood-thinning drugs has received the U.S. Food and Drug Administration's breakthrough-device designation.
The dialysis system is manufactured using Endexo, a polymer that inhibits adhesion of proteins and platelets to the device surface and reduces clot risk. The system also uses Citrasate as a dialysate, a solution of pure water, electrolytes and salts that pulls toxins from the blood.
Fresenius' unit Fresenius Medical Care North America Holdings LP acquired an exclusive worldwide license from Interface Biologics Inc. to use Endexo technology to manufacture various components of its dialysis system.
The U.S. regulator granted breakthrough device designation to Fresenius' computer-assisted ultrafiltration control software in March.
The breakthrough designation speeds up the development and review process for technologies that provide more effective treatment or diagnosis of life-threatening or debilitating diseases.