Nuwellis Multicenter Pediatric Aquadex Study Published in Pediatric Nephrology: 91 Children at Seven Hospitals, 87% Survived Their Treatment Course
Medical technology company Nuwellis (Nasdaq: NUWE), based in Minneapolis, Minnesota, announced on October 27 that results from its ULTRA-Peds Registry have been published in Pediatric Nephrology, providing multicenter clinical evidence for its Aquadex SmartFlow ultrafiltration system in pediatric patients.
The study pooled data on 91 children treated with Aquadex at seven children's hospitals; 62% weighed less than 10 kilograms, including 41 infants under 5 kilograms. Results showed 87% of patients survived their treatment course and 86.5% of procedures were completed without interruption. First author Dr. Michelle C. Starr said the registry brings together clinical experience from seven children's hospitals and provides real-world evidence for some of the smallest and most vulnerable patients.
The study was funded by Nuwellis through a grant to the Acute Kidney Injury Critical Care Research Foundation, and the company had no input into the data analysis or publication. Earlier this year, Nuwellis completed a pre-submission meeting with the U.S. Food and Drug Administration seeking to expand Aquadex's cleared labeling from patients weighing 20 kilograms and above to those weighing 5 kilograms and above.
Source: GSM · USA (original Chinese edition)
Photo: 医护人员为婴儿做检查（资料图）。图片：Joseph A. Boomhower，美国海军，公共领域，经Wikimedia Commons。 / A medical officer examines an infant (file photo). Photo: Joseph A. Boomhower, U.S. Navy, public domain, via Wikimedia Commons.
