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Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners
News Release | Published 10.24.2019
Endexo® Receives FDA Breakthrough Device Designation | FMCNA
Surface Modifying Macromolecules in Dialyzers and Bloodlines are Paired with Dialysate Formula to Prevent Clots
WALTHAM, Mass. – Oct. 24, 2019 – Fresenius Medical Care North America (FMCNA), the nation’s leading provider of kidney care products and services, announced today that 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.”
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.”
This FDA Breakthrough Device Designation is the second that the company has earned this year. In March, the FDA granted the designation to FMCNA’s computer-assisted ultrafiltration (UF) control software currently in development to improve fluid management during hemodialysis and personalize treatments.
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.
Research supporting the development of this new system will be presented at the American Society of Nephrology’s Kidney Week in November.
About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
© 2019 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo and Fresenius Renal Technologies are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. Citrasate is a registered trademark of Advanced Renal Technologies used under license. Endexo is a registered trademark of Interface Biologics, Inc. used under license. All other trademarks are the property of their respective owners.