Fresenius Medical Care North America (NYSE:FMS) said today that it won breakthrough device designation from the FDA for the new hemodialysis system it’s developing.
Waltham, Mass.-based Fresenius said its Endexo antithrombogenic additive is being incorporated into the manufacturing of dialyzers and bloodlines. The device is a polymer made of modifying molecules designed to inhibit the adsorption of protein and platelets for reducing clot risk and increasing hemocompatibility.
The new device’s aim is to prevent blood clotting without the use of blood thinner medication. Citrasate dialysate would be used with the new dialyzers and bloodlines as part of Fresenius’ new system, according to a news release. Fresenius added that it has an exclusive worldwide license from Interface Biologics to apply Endexo technology to multiple hemodialysis components.
Fresenius said this is the second breakthrough designation granted to the company by the FDA this year. In March, the company’s computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis won a breakthrough nod.
“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,” Fresenius global research & development CEO Olaf Schermeier said in prepared remarks. “Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients’ well-being.”
“This new dialysis system builds on our commitment to innovate in ways that continuously improve patient safety and health outcomes,” added renal therapies group president Mark Costanzo. “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 chief medical officer Dr. Robert Kossmann. “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.”
Shares of FMS were up 0.03% at $32.74 per share in mid-afternoon trading today.
