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.--->
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