New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring for Pediatric Patients
The publication is a single-center case study review of pediatric patients with hypoalbuminemia and severe fluid overload. Patients were treated with Nuwellis’ Aquadex® ultrafiltration therapy with continuous hematocrit monitoring to guide isotonic fluid removal. The study concluded that the therapy successfully treated small patients without hemodynamic instability or other complications, demonstrating that Aquadex is an effective treatment option for fluid overload.
“We’re proud to share new evidence supporting the clinical need and applications for Aquadex among pediatric patients, and we’re grateful to Dr.
“Managing fluid overload for pediatric patients can be challenging, but these new data and our growing library of evidence support our view that Aquadex can provide a safe and effective method for restoring fluid balance,” said
Effectively managing fluid overload for pediatric patients is critical. Fluid overload is associated with significant increases in mortality in pediatric patients. Research has shown that a 3% increase in mortality is observed for every 1% increase in fluid overload among these patients. 2,3
Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. The device’s built-in, customizable hematocrit monitoring technology provides real-time measurement of percent blood volume changes that can be tailored to individual patients’ needs. A customizable fluid removal rate is particularly important for pediatric patients, who have a small amount of blood in their bodies. The Aquadex system is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
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1 Starr MC, et al. Pediatric Nephrology,
2 Sutherland SM, et al.
3 Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394-1399,