CHF Solutions’ Aquadex FlexFlow® Ultrafiltration System Receives FDA IDE Approval for Clinical Study for Pediatric Use
EDEN PRAIRIE, Minn., June 29, 2017 (GLOBE NEWSWIRE) — CHF Solutions, Inc., (fka Sunshine Heart, Inc.) (NASDAQ:CHFS) announced today that researchers in the Stanford University School of Medicine’s Department of Pediatrics have received FDA Investigational Device Exemption (IDE) approval to conduct a clinical study to evaluate the safety and effectiveness of CHF Solutions’ Aquadex FlexFlow Aquapheresis System for diuretic-resistant fluid overload in children with acute decompensated heart failure. The randomized multi-center, non-blinded clinical study will assess up to 45 children and young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload. Heart failure is the leading cause of death in children with cardiomyopathy and congenital heart disease.
The study seeks to determine whether Aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to optimal medical therapy. In addition, the impact on heart failure symptoms using a novel pediatric heart failure symptoms score developed by the investigators, adverse outcomes and the need for medical management will be evaluated as secondary endpoints. The study is being led by Stanford’s Christopher Almond, Associate Professor of Pediatrics (Cardiology), and David Kwiatkowski, Clinical Assistant Professor of Pediatrics (Cardiology).
“We are pleased that the researchers have received FDA approval to proceed with this IDE study,” said John Erb, Chairman and CEO of CHF Solutions. “Given the limitations of patient unresponsiveness to diuretic therapies over time, our solution represents a potentially transformative future standard of care. We look forward to the clinical data results and to continuing our efforts to provide patients with additional treatment options for the treatment of heart failure,” Mr. Erb concluded.
About CHF Solutions
CHF Solutions, Inc. (Nasdaq:CHFS) is an early-stage medical device company focused on commercializing the Aquadex FlexFlow® Ultrafiltration System. The company’s commercial product, the Aquadex system, is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. The company’s objective is to improve the quality of life for patients with heart failure and related conditions. CHF Solutions is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The company has been listed on the NASDAQ Capital Market since February 2012.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future research, establishing UF as a standard of care for the treatment of fluid overload in heart failure patients, the potential for treatment protocols and guidelines to improve future patient outcomes, and events or developments that we expect or anticipate will occur in the future. 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 risk associated with our ability to execute on our recently announced strategic realignment, 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 SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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