CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More
CHF SOLUTIONS INC (CHFS)
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Source: GlobeNewswire
EDEN PRAIRIE, Minn., Feb. 26, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS) today announced FDA 510(k) clearance in the U.S. of its next generation Aquadex SmartFlow console for use in adult and pediatric patients who weigh 20kg or more. The console is a simple, gentle, and smart solution for treatment of patients suffering from hypervolemia (fluid overload). In a retrospective, multi-center study, 32 pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex system and 97% (31/32) survived to the end of therapy.1 “For many types of pediatric patients, the available therapies require very high relative extracorporeal blood volumes, which can be challenging,” said Stuart Goldstein, M.D., Professor of Pediatrics and Director, Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center and a paid consultant of CHF Solutions. “The Aquadex SmartFlow system allows us to initiate therapy with excellent
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