Fresenius Medical Care (NYSE:FMS) received FDA breakthrough device designation for its hemodialysis system, which is being developed for the prevention of blood clotting without the use of blood thinner medication.
Many patients are prescribed blood thinners, which can have serious side effects, to prevent clots during dialysis procedures. Fresenius has incorporated the antithrombogenic additive, Endexo, which was acquired from closely-held Interface Biologics earlier this year, into various hemodialysis components, including dialyzers and blood lines, to reduce dialysis patients’ need for blood thinners.
“We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients,” Fresenius’ CMO, Dr. Robert Kossmann, said in a statement.
“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 market as quickly as possible,” he added.
