Fresenius Medical Care North America (FMCNA) announced the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new hemodialysis system, currently in development, that aims to prevent blood clotting without the use of blood thinner medication in most patients.
The antithrombogenic additive, Endexo®, is being incorporated into the manufacturing process of dialyzers and bloodlines. Endexo is a polymer made of surface modifying molecules that are designed to inhibit the adsorption of protein and platelets, which in turn can potentially reduce clot risk and increase hemocompatibility. Citrasate® dialysate would be used with the new dialyzers and bloodlines as part of this novel system.
"Harnessing our innovational expertise, we continuously strive to make significant advances in our products and provide new solutions for people with chronic kidney disease worldwide," said Dr. Olaf Schermeier, Chief Executive Officer for Global Research and Development at Fresenius Medical Care. "Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients' well-being."
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Many dialysis patients are currently prescribed blood thinners, like heparin, to reduce the risk of clotting as blood travels from their body, through bloodlines, and into the dialyzers that filter out toxins. The new technology aims to reduce the need for these blood thinners, which can have dangerous side effects. Fresenius Medical Care holds an exclusive worldwide license from Interface Biologics to apply the Endexo technology to various hemodialysis components, including dialyzers and blood lines.
"This new dialysis system builds on our commitment to innovate in ways that continuously improve patient safety and health outcomes," said Mark Costanzo, president of FMCNA's Renal Therapies Group. "We are proud to be leading the way in designing the future of life-sustaining dialysis treatments."
"We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients," said Dr. Robert Kossmann, chief medical officer for FMCNA. "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."
The FDA Breakthrough Device Program seeks to provide patients with faster access to technologies that provide more effective treatment or diagnosis of life-threatening or debilitating diseases by speeding up the development and review process. The FDA announced final guidance for the Breakthrough Devices Program on December 19, 2018. The program was established by the 21st Century Cures Act.