CHF Solutions, Inc. (CHFS) announced that researchers in the Stanford University School of Medicine's Department of Pediatrics have received FDA Investigational Device Exemption (IDE) approval to conduct a clinical study to evaluate the safety and effectiveness of the company's Aquadex FlexFlow Aquapheresis System for diuretic-resistant fluid overload in children with acute decompensated heart failure.
The study seeks to determine whether Aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to optimal medical therapy. The impact on heart failure symptoms using a novel pediatric heart failure symptoms score developed by the investigators, adverse outcomes and the need for medical management will be evaluated as secondary endpoints.
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