CHF Solutions Receives FDA Clearance for Aquadex SmartFlow System

CHF Solutions has announced U.S. Food and Drug Administration (FDA) 510(k) clearance in the United States 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 percent (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 hemodynamic stability due to the low extracorporeal value of 35ml. In addition, the hematocrit monitoring feature helps caregivers maintain appropriate fluid balance in their patients.”
 
“With the approval of the Aquadex SmartFlow, traditionally underserved pediatric patients will benefit from ultrafiltration therapy that has shown positive clinical results and has strong interest from pediatric hospitals,” said John Erb, chairman and CEO of CHF Solutions. “FDA clearance for pediatric patients is a significant milestone for the company and the result of strong execution from our team.”
 
The Aquadex SmartFlow system is a clinically proven therapy that provides a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to eight hours) or extended (longer than eight hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.

Reference 
¹ https://cjasn.asnjournals.org/content/early/2019/08/27/CJN.03240319