Hypervolemia treatment system nets FDA approval
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CHF Solutions announced the FDA cleared its ultrafiltration device for the treatment of hypervolemia in adults and pediatric patients who weigh 20 kg or more.
The console (Aquadex SmartFlow, CHF Solutions) is indicated for the removal of excess fluid from patients with hypervolemia, otherwise known as fluid overload. The console is indicated for use up to 8 hours — or more in hospitalized patients — when hypervolemia is unresponsive to medical management or diuretics.
“For many types of pediatric patients, the available therapies require very high relative extracorporeal blood volumes, which can be challenging,” Stuart Goldstein, MD, professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, said in a press release. “The Aquadex SmartFlow system allows us to initiate therapy with excellent hemodynamic stability due to the low extracorporeal value of 35 ml. In addition, the hematocrit monitoring feature helps caregivers maintain appropriate fluid balance in their patients.”
According to a retrospective, multicenter study published in the Clinical Journal of the American Society of Nephrology, 32 pediatric patients with hypervolemia, weighing over 20 kgs, were treated with the Aquadex console and 97% survived to the end of therapy.
“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,” John Erb, chairman and CEO of CHF Solutions, said in the release. “FDA clearance for pediatric patients is a significant milestone for the company and the result of strong execution from our team.”
Reference:
Menon S, et al. Clin J Am Soc Nephrol. 2020;doi:10.2215/CJN.03240319.
Disclosures: Goldstein reports that he is a consultant for CHF Solutions. Erb is an employee of CHF Solutions.