Nuwellis Initiates REVERSE-HF Study to Evaluate Ultrafiltration for Heart Failure Patients with Fluid Overload
REVERSE-HF is a multicenter, open-label, randomized controlled trial with an adaptive design that will be conducted across
“Traditional diuretics can result in mixed outcomes, and people with heart failure who are experiencing fluid overload don’t always respond to them,” said
The primary effectiveness endpoint of REVERSE-HF will evaluate mortality and heart failure events within 30 days and 90 days as a comparison between Aquadex therapy and intravenous (IV) loop diuretics. The study will assess safety parameters, including but not limited to cardiovascular and renal related adverse events of special interest.
Heart failure can disrupt normal kidney functions and lower their ability to remove sodium from the body, which can cause excessive water retention resulting in fluid overload. Over 1 million heart failure hospitalizations occur annually in
“Heart failure patients suffering from fluid overload are frequently readmitted to the hospital, resulting in a tremendous burden to both patients and our healthcare systems,” said
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
1 Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445.
Matt Bacso, CFA Gilmartin Group LLCmatt.email@example.com MEDIA: Sarah LundbergHealth+Commerce firstname.lastname@example.org
Source: Nuwellis, Inc.