Nuwellis Announces Data Demonstrating Statistically Superior Clinical Benefit of Aquadex Therapy in Reducing Heart Failure Events and Mortality at the 2022 HFSA Meeting
“The re-evaluation of AVOID-HF, using the Win-Ratios calculation, shows that adjustable ultrafiltration is safe and more effective than adjustable IV diuretics in reducing heart failure events for hospitalized heart failure patients,” said
The AVOID-HF outcomes were evaluated using a composite endpoint consisting of cardiovascular (CV) mortality within 90 days, heart failure (HF) events within 30-days, and time-to-first HF event within 90 days. Adjustable Ultrafiltration (AUF) was statistically superior compared to Adjustable IV Loop Diuretics (ALD) with 81% more wins (
“The results of this analysis support the clinical benefits of providing ultrafiltration with the Aquadex System in reducing readmissions and rehospitalization in fluid overloaded heart failure patients,” said
The AVOID-HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure) prospective, multicenter, randomized controlled trial tested the hypothesis that patients hospitalized for heart failure (HF) and treated with ultrafiltration would have a longer time to their first heart failure event within 90 days after hospital discharge compared to those receiving IV loop diuretics. The study was trending favorably when the study sponsor terminated it before reaching full enrollment for reasons unrelated to patient safety or clinical futility. At the time, analysis of the AVOID-HF trial data was inconclusive due to the lower-than-planned sample size. However, the Finkelstein-Schoenfeld method of hierarchical Win Ratios increases statistical precision in demonstrating significant differences in clinical outcomes between treatment arms, while requiring a smaller study sample size.
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable 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.
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2022 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the impact of the COVID-19 pandemic, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the
Chief Financial Officer, Nuwellis, Inc.
Gilmartin Group LLC
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Source: Nuwellis, Inc.