Nuwellis Announces Acceptance of Multicenter Pediatric Aquadex Study in Pediatric Nephrology
Key Highlights
- ➤91 pediatric patients studied across seven children’s hospitals
- ➤87% of patients survived their Aquadex treatment course
- ➤86.5% of procedures completed without interruption
- ➤62% of patients weighed less than 10 kg
- ➤Nuwellis seeks FDA labeling expansion to patients weighing 5 kg and above
Expert Statements
Michelle C. Starr, M.D., MPH; first author of the ULTRA-Peds publication
“The ULTRA-Peds Registry represents an important addition to the growing body of clinical evidence supporting Aquadex therapy in pediatric patients. This study brings together clinical experience from seven pediatric hospitals and provides valuable real-world evidence on the use of Aquadex in some of our smallest and most vulnerable patients.”
Stuart Goldstein, M.D., Director of Clinical Strategy at Nuwellis and co-author of the study
“Providing extracorporeal kidney support to infants and small children presents significant clinical and technical challenges, particularly given their small blood volume and the precision required to manage fluid balance safely. The ULTRA-Peds Registry provides important multicenter data on both clinical outcomes and device performance, demonstrating the feasibility of Aquadex therapy in critically ill pediatric patients, including very small infants. These findings add to our understanding of how to optimize kidney support and fluid management in this unique patient population.”
MINNEAPOLIS, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced the publication of results from a multicenter study titled "Kidney Support in Infants and Children using Aquadex: Findings from the ULTRA-Peds Registry” in Pediatric Nephrology. It provides important clinical evidence supporting the use of the Company's Aquadex SmartFlow(®) System ultrafiltration technology in pediatric patients, including infants and children weighing less than 10 kg. The publication examining the outcomes and implications was authored by Michelle C. Starr, M.D., MPH; Stuart L. Goldstein, M.D.; Shina Menon, M.D.; David Askenazi, M.D., MSPH; David M. Kwiatkowski, M.D.; and Alexandru R. Constantinescu, M.D. The ULTRA-PEDS study was funded by Nuwellis, Inc via a grant to the Acute Kidney Injury Critical Care Research Foundation, managed by Watermark Partners (Indianapolis, IN). Nuwellis had no input on data analysis, presentation or publication of these results.
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