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CHF Solutions Reports IDE Approval For Aquadex FlexFlow Aquapheresis System

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

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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